medcomp.net DIALYSIS & VASCULAR ACCESS PRODUCTS
medcomp.net
DIALYSIS & VASCULAR ACCESS PRODUCTS medcomp® develops, manufactures, markets and supports cutting-edge vascular access devices and accessories to meet the clinical needs of the medical industry, particularly in the vascular access field. Our company’s engineering and applications expertise provides superior products whose progressive designs accommodate advances in medicine and whose quality anticipates the requirements of our professional clients and the patients they serve. Currently one of the world’s largest manufacturers of dialysis and centrally terminating venous catheters, Medcomp is, and always has been, on the cutting edge of new vascular access device technologies. Message to the Customers In everything we do, from research and development to manufacturing, packaging, delivery and support, our first consideration is the patient. It is vitally important to us that, regardless of age, socio-economic status or type of healthcare treatment required, that every patient receives the best that Medcomp can provide. We dedicate ourselves to supplying the highest quality, innovation and customer service with every device we sell. Our History Medcomp was founded in 1978 to manufacture and market vascular access catheters for acute hemodialysis. At that time catheter designs were simple, consisting of a single lumen catheter for single-needle dialysis or double lumen catheters for continuous-flow dialysis. As the need for new products grew with the advent of increasingly complex procedures, Medcomp emerged as a premier developer of innovative devices using our in-house staff of engineers working in conjunction with some of the preeminent physicians in the field of nephrology and vascular access. Building on our pioneering Tesio®, Split Cath® and Duo-Flow® products, Medcomp continues to dominate the market in both new and proven dialysis, interventional and accessory devices. Today our contributions to the medical devices field total more than 75 product lines and thousands of distinct products. Development & Production Medcomp’s reputation and growth can be attributed to our diversely disciplined group of engineers specializing in biomedical and mechanical engineering, collaboration with esteemed professionals, and readiness to listen to suggestions and comments frommembers of the medical community. By continually improving on existing technology, Medcomp is able to provide a catheter to suit every medical requirement while also considering the patient’s comfort. Patients, physicians and nurses can rely on a Medcomp device to do its job and help make any treatment a more successful one. All Medcomp products are developed in accordance with all FDA Quality Systems Regulations, European Medical Device Directives (CE), Japanese GMPI and numerous other international regulations and standards to ensure safety and performance. Medcomp is ISO 13485:2016 and MDSAP certified by BSI Assurance UK Limited, maintains certification to Annex II as defined in Medical Device Directive 93/42 EEC, and is certified by BSI Group The Netherlands N.V. We are audited regularly.
P: 215-256-4201 • F:215-256-1787 • medcomp.net TABLE OF CONTENTS LONG TERM Symetrex® . . . . . . . . . . . . . . . . . . . . 2 SHORT TERM Duo-Split® . . . . . . . . . . . . . . . . . . . . 6 Hemo-Cath® ST . . . . . . . . . . . . . . . 8 Duo-Flow® . . . . . . . . . . . . . . . . . . . . 9 Duo-Flow® III . . . . . . . . . . . . . . . . . . 10 Duo-Flow® Soft-Line® . . . . . . . . . . . 11 Duo-Flow® Side X Side . . . . . . . . . . 12 Duo-Flow® 400XL . . . . . . . . . . . . . . 13 Free-Flow® ST . . . . . . . . . . . . . . . . . 14 Trio-CT® . . . . . . . . . . . . . . . . . . . . . 15 T-3® CT . . . . . . . . . . . . . . . . . . . . . . 16 Tri-Flow . . . . . . . . . . . . . . . . . . . . . . 17 Femoral . . . . . . . . . . . . . . . . . . . . . 18 Subclavian . . . . . . . . . . . . . . . . . . . 18 PICCs Pro-PICC® . . . . . . . . . . . . . . . . . . . . 22 Vascu-PICC® . . . . . . . . . . . . . . . . . . 24 Vascu-PICC® TL . . . . . . . . . . . . . . . 25 Vascu-PICC® TLS . . . . . . . . . . . . . . 26 Valved Pro-PICC® . . . . . . . . . . . . . . 28 Valved Vascu-PICC® 28 MIDLINE CT Midline . . . . . . . . . . . . . . . . . . . . 32 Arch-Flo™ CT Midline . . . . . . . . . . . 34 CVCs Pro-Line® . . . . . . . . . . . . . . . . . . . . . 38 Vascu-Line® . . . . . . . . . . . . . . . . . . 40 CVC Catheter . . . . . . . . . . . . . . . . . 41 PORTS Dignity® CT . . . . . . . . . . . . . . . . . . . 44 Dignity® Mini . . . . . . . . . . . . . . . . . . 46 Dignity® Titanium . . . . . . . . . . . . . . 47 Pro-Fuse® CT . . . . . . . . . . . . . . . . . 48 Direct Micropuncture Ports . . . . . . . 49 PERITONEAL V-Series . . . . . . . . . . . . . . . . . . . . . 52 I-Series . . . . . . . . . . . . . . . . . . . . . . 54 X-Series . . . . . . . . . . . . . . . . . . . . . 55 ACCESSORIES Micro-Stick® . . . . . . . . . . . . . . . . . . 58 Tearaway Micro Introducer . . . . . . . 60 Super Sharp Introducer Needles . . . . . . . . . . . . . 60 Introducer Needle . . . . . . . . . . . . . . 60 Sheath Dilators . . . . . . . . . . . . . . . . 61 Dilators . . . . . . . . . . . . . . . . . . . . . . 62 Guidewire Syringe . . . . . . . . . . . . . . 62 Guidewires . . . . . . . . . . . . . . . . . . . 63 Trocars & Tunnelers . . . . . . . . . . . . 64 CATHETER LOCK SOLUTION DuraLock-C® . . . . . . . . . . . . . . . . . . 68 ORDERING INFO & POLICIES
LONG TERM HEMODIALYSIS CATHETERS Symetrex® IMPORTANT RISK INFORMATION SYMETREX® Indications for Use: The Symetrex® Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis. It may be inser ted percutaneously. Catheters with greater than 37 cm implant length are indicated for femoral placement. Contraindications: Do not use this catheter in thrombosed vessels or for subclavian puncture when ventilator is in use. This device is contraindicated whenever: Used for any purpose other than indicated in these instructions. The presence of other device related infection, or septicemia is known or suspected. Severe chronic obstructive lung disease is present. Tissue factors in the localized area of device placement will prevent proper device stabilization and/or access. Venous thrombosis or vascular surgical procedures have occurred at the prospective placement site. Post irradiation of prospective inser tion site. Refer to Instructions for Use provided with the product for complete instructions, warnings, precautions, and contraindications. Observe all instructions for use prior to using products. Failure to do so may result in patient complications. Long Term
LONG TERM SYMETREX® Material Tip Design French Size Polyurethane Symmetrical 15.5F Insertion Type Antegrade Configuration Straight Double “D” Internal Lumen Design Refer to the Table of Contents for Important Risk Information regarding this device. Symmetrical Reversible Tip High Flow Rate/Lower Pressure Designed to Preserve Access WITH SIDEHOLES BASIC SET WITH STYLETS MBPS019SE. 15.5F X 19CM SYMETREX® BASIC SET W/ STYLETS 5/BOX MBPS023SE. 15.5F X 23CM SYMETREX® BASIC SET W/ STYLETS 5/BOX MBPS028SE. 15.5F X 28CM SYMETREX® BASIC SET W/ STYLETS 5/BOX MBPS033SE. 15.5F X 33CM SYMETREX® BASIC SET W/ STYLETS 5/BOX BASIC SET WITHOUT STYLETS MBNS037SE. 15.5F X 37CM SYMETREX® BASIC SET W/O STYLETS 5/BOX MBNS042SE. 15.5F X 42CM SYMETREX® BASIC SET W/O STYLETS 5/BOX UPGRADE KIT MUPS019SE. 15.5F X 19CM SYMETREX® UPGRADE KIT 5/BOX MUPS023SE. 15.5F X 23CM SYMETREX® UPGRADE KIT 5/BOX MUPS028SE. 15.5F X 28CM SYMETREX® UPGRADE KIT 5/BOX MUPS033SE. 15.5F X 33CM SYMETREX® UPGRADE KIT 5/BOX BASIC SET CONTENTS WITH STYLETS: (1) Catheter (2) Stylets (1) Introducer Needle (1) Guidewire (2) Dilator (1) Tunneler (1) Valved Peelable Introducer (2) End Caps (1) Patient ID Card (1) Patient Label BASIC SET CONTENTS WITHOUT STYLETS: (1) Catheter (1) Introducer Needle (1) Guidewire (2) Dilator (1) Tunneler (1) Valved Peelable Introducer (2) End Caps (1) Patient ID Card (1) Patient Label UPGRADE KIT CONTENTS: (1) Catheter (2) Stylets (2) End Caps (1) Patient ID Card (1) Patient Label 2
LONG TERM SYMETREX® WITHOUT SIDEHOLES BASIC SET WITH STYLETS MBPS019E. 15.5F X 19CM SYMETREX® BASIC SET W/ STYLETS 5/BOX MBPS023E. 15.5F X 23CM SYMETREX® BASIC SET W/ STYLETS 5/BOX MBPS028E. 15.5F X 28CM SYMETREX® BASIC SET W/ STYLETS 5/BOX MBPS033E. 15.5F X 33CM SYMETREX® BASIC SET W/ STYLETS 5/BOX BASIC SET WITHOUT STYLETS MBNS037E. 15.5F X 37CM SYMETREX® BASIC SET W/O STYLETS 5/BOX MBNS042E. 15.5F X 42CM SYMETREX® BASIC SET W/O STYLETS 5/BOX UPGRADE KIT MUPS019E. 15.5F X 19CM SYMETREX® UPGRADE KIT 5/BOX MUPS023E. 15.5F X 23CM SYMETREX® UPGRADE KIT 5/BOX MUPS028E. 15.5F X 28CM SYMETREX® UPGRADE KIT 5/BOX MUPS033E. 15.5F X 33CM SYMETREX® UPGRADE KIT 5/BOX BASIC SET CONTENTS WITH STYLETS: (1) Catheter (2) Stylets (1) Introducer Needle (1) Guidewire (2) Dilator (1) Tunneler (1) Valved Peelable Introducer (2) End Caps (1) Patient ID Card (1) Patient Label BASIC SET CONTENTS WITHOUT STYLETS: (1) Catheter (1) Introducer Needle (1) Guidewire (2) Dilator (1) Tunneler (1) Valved Peelable Introducer (2) End Caps (1) Patient ID Card (1) Patient Label UPGRADE KIT CONTENTS: (1) Catheter (2) Stylets (2) End Caps (1) Patient ID Card (1) Patient Label 3
IMPORTANT RISK INFORMATION DUO-SPLIT® Indications for Use: The Medcomp® Duo-Split® Double Lumen Catheter is indicated for use in attaining Shor t-Term vascular access for Hemodialysis and Apheresis. It may be inser ted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate inser tion sites include subclavian vein and femoral vein as required. The curved Duo-Split® Catheter is intended for internal jugular inser tion. This catheter is indicated for a duration less than (30) days. Contraindications: This catheter is intended for Shor t-Term vascular access only and should not be used for any purpose other than indicated in these instructions. HEMO-CATH® ST – DOUBLE LUMEN Indications for Use: The Medcomp’s Hemo-Cath® Silicone Double Lumen Catheter can be utilized for temporary access for hemodialysis, hemoperfusion, or apheresis therapy. The cannula may be inser ted via the Seldinger technique due to the inner stylet, increasing linear strength. The stylet is removed after inser tion, leaving the soft silicone cannula in the body. The flexible silicone make-up conforms well to the vessel anatomy, resulting in higher patient tolerance during extended use. Contraindications: This catheter is intended for Shor t-Term vascular access only and should not be used for any purpose other than indicated in these instructions. HEMO-CATH® ST – SINGLE LUMEN Indications for Use: The Medcomp® Hemo-Cath® Silicone Single Lumen Catheter is designed for acute hemodialysis and apheresis. It may be inser ted percutaneously and is ideally placed in the jugular vein. Although this catheter may be inser ted into the subclavian or femoral, the internal jugular is the preferred site. This catheter is indicated for a duration less than (30) days. Contraindications: This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels. DUO-FLOW® Indications for Use: The Medcomp® Duo-Flow® Catheter is indicated for use in attaining Shor t-Term vascular access for Hemodialysis and Apheresis. It may be inser ted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate inser tion sites include subclavian vein or femoral vein as required. The curved Duo-Flow® Catheter is intended for internal jugular vein inser tion. This catheter is indicated for a duration less than (30) days. For femoral placement, monitor catheter condition closely. Contraindications: This catheter is intended for Shor t-Term vascular access only and should not be used for any purpose other than indicated in these instructions. DUO-FLOW® III Indications for Use: The Medcomp® Duo-Flow® Step-Tip Catheter is indicated for use in attaining Shor t-Term vascular access for Hemodialysis and Apheresis. It may be inser ted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate inser tion sites include subclavian vein or femoral vein as required. The curved Duo-Flow® Step-Tip Catheter is intended for internal jugular vein inser tion. This catheter is indicated for a duration less than (30) days. For femoral placement, monitor catheter condition closely. Contraindications: This catheter is intended for Shor t-Term vascular access only and should not be used for any purpose other than indicated in these instructions. DUO-FLOW® SOFT-LINE® Indications for Use: The Medcomp® Soft-Line® Catheter is indicated for use in attaining Shor t-Term vascular access for Hemodialysis and Apheresis. It may be inser ted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate inser tion sites include subclavian vein or femoral vein as required. The curved Soft-Line® Catheter is intended for internal jugular vein inser tion. This catheter is indicated for a duration less than (30) days. For femoral placement, monitor catheter condition closely. Contraindications: This catheter is intended for Shor t-Term vascular access only and should not be used for any purpose other than indicated in these instructions. DUO-FLOW® SIDE X SIDE Indications for Use: The Medcomp® Side by Side Double Lumen Catheter is designed for acute hemodialysis and apheresis. It may be inser ted percutaneously and is ideally placed in the jugular vein. Although this catheter may be inser ted into the subclavian or femoral, the internal jugular is the preferred site. This catheter is indicated for a duration less than (30) days. Contraindications: This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels. DUO-FLOW® 400XL Indications for Use: The Medcomp® Duo-Flow and Duo-Flow 400XL Double Lumen Catheters are designed for acute hemodialysis and apheresis. They may be inser ted percutaneously and are ideally placed in the internal jugular vein. Although these catheters may be inser ted into the subclavian or femoral vein, the internal jugular is the preferred site. Contraindications: This catheter is intended for Shor t-Term vascular access only and should not be used for any purpose other than indicated in these instructions.
SHORT TERM HEMODIALYSIS CATHETERS Duo-Split® Hemo-Cath® ST Duo-Flow® Duo-Flow® III Duo-Flow® Soft-Line® Duo-Flow® Side X Side Duo-Flow® 400XL Free-Flow® ST Trio-CT® T-3® CT Tri-Flow Femoral Subclavian FREE-FLOW® ST Indications for Use: The ST Catheter is indicated for use in attaining Shor t-Term vascular access for Hemodialysis, Hemofiltration, and Apheresis. It may be inser ted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate inser tion sites include the subclavian and femoral veins as required. This catheter is indicated for a duration less than (30) days. For femoral placement, monitor catheter condition closely. Contraindications: This catheter is intended for Shor t-Term vascular access only and should not be used for any purpose other than indicated in these instructions. TRIO-CT® Indications for Use: The Trio-CT® Triple Lumen Catheter is indicated for use in attaining shor t-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring. The catheter is intended to be inser ted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. Contraindications: This catheter is intended for shor t-term (less than 30 days) vascular access only and should not be used for any purpose other than indicated in these instructions. This device is also contraindicated: When the presence of device related infection, bacteremia, or septicemia is known or suspected. When the patient’s body size is insufficient to accommodate the size of the implanted device. When the patient is known or is suspected to be allergic to materials contained in the device. If the prospective inser tion site has been previously irradiated. If the prospective placement site has previously suffered episodes of venous thrombosis or vascular surgical procedures. If local tissue factors may prevent proper device stabilization and/or access. T-3® CT Indications for Use: The Medcomp® T-3® CT Catheter is a triple lumen catheter indicated for use in attaining shor t-term vascular access for hemodialysis, apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring. The catheter is intended to be inser ted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. Contraindications: This catheter is intended for shor t-term (less than 30 days) vascular access only and should not be used for any purpose other than indicated in these instructions. This device is also contraindicated: When the presence of device related infection, bacteremia, or septicemia is known or suspected. When the patient’s body size is insufficient to accommodate the size of the implanted device. When the patient is known or is suspected to be allergic to materials contained in the device. If the prospective inser tion site has been previously irradiated. If the prospective placement site has previously suffered episodes of venous thrombosis or vascular surgical procedures. If local tissue factors may prevent proper device stabilization and/or access. TRI-FLOW Indications for Use: The Medcomp® Tri-Flow Catheter is indicated for use in attaining Shor t-Term vascular access for Hemodialysis and Apheresis. It may be inser ted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate inser tion sites include subclavian vein or femoral vein as required. The Medcomp® Tri-Flow Catheter is intended to be used less than (30) days. Contraindications: This catheter is intended for Shor t-Term vascular access only and should not be used for any purpose other than indicated in these instructions. Do not inser t catheter in thrombosed vessels. FEMORAL Indications for Use: The Medcomp® Femoral Catheter is designed for acute hemodialysis and apheresis. It may be inser ted percutaneously and the preferred site is the femoral vein. This catheter is indicated for a duration less than (30) days. Contraindications: This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels. SUBCLAVIAN Indications for Use: The Subclavian Catheter is designed for acute hemodialysis and apheresis. It may be inser ted percutaneously and the preferred site is the subclavian vein. This catheter is indicated for a duration less than (30) days. Contraindications: This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels. Refer to Instructions for Use provided with the product for complete instructions, warnings, precautions, and contraindications. Observe all instructions for use prior to using products. Failure to do so may result in patient complications. Shor t Term
SHORT TERM DUO-SPLIT® Material Polyurethane Tip Design Split Tip French Size 13F Configurations Straight, Pre-Curved, IJ Split Tip Design Arteriovenous Weave with Dual Stylet Raulerson IJ Configuration Double “D” Internal Lumen Design Refer to the Table of Contents for Important Risk Information regarding this device. 6 Shor t Term
SHORT TERM DUO-SPLIT® BASIC SET DSP134SE 13F X 12CM DUO-SPLIT® BASIC SET, STRAIGHT 5/BOX DSP136SE 13F X 15CM DUO-SPLIT® BASIC SET, STRAIGHT 5/BOX DSP138SE 13F X 20CM DUO-SPLIT® BASIC SET, STRAIGHT 5/BOX DSP139SE 13F X 24CM DUO-SPLIT® BASIC SET, STRAIGHT 5/BOX DSP134PSE 13F X 12CM DUO-SPLIT® BASIC SET, PRE-CURVED 5/BOX DSP136PSE 13F X 15CM DUO-SPLIT® BASIC SET, PRE-CURVED 5/BOX DSP138PSE 13F X 20CM DUO-SPLIT® BASIC SET, PRE-CURVED 5/BOX DSP139PSE 13F X 24CM DUO-SPLIT® BASIC SET, PRE-CURVED 5/BOX DSP134IJSE 13F X 12CM DUO-SPLIT® BASIC SET, IJ 5/BOX DSP136IJSE 13F X 15CM DUO-SPLIT® BASIC SET, IJ 5/BOX DSP138IJSE 13F X 20CM DUO-SPLIT® BASIC SET, IJ 5/BOX DSP139IJSE 13F X 24CM DUO-SPLIT® BASIC SET, IJ 5/BOX BASIC SET CONTAINS: (1) Catheter w/ Stylets (2) End Caps (1) Dilator (1) Introducer Needle (1) Guidewire 7
SHORT TERM BASIC SET SL12P 8F X 12CM HEMO-CATH® ST 10/BOX SL12 11.5F X 12CM HEMO-CATH® ST 10/BOX SL15E 11.5F X 15CM HEMO-CATH® ST 10/BOX SL20E 11.5F X 20CM HEMO-CATH® ST 10/BOX SL24E 11.5F X 24CM HEMO-CATH® ST 10/BOX SL27 11.5F X 27CM HEMO-CATH® ST 10/BOX SDL136E 13.5F X 15CM HEMO-CATH® ST 10/BOX SDL138E 13.5F X 20CM HEMO-CATH® ST 10/BOX SDL139E 13.5F X 24CM HEMO-CATH® ST 10/BOX SDL1311E 13.5F X 28CM HEMO-CATH® ST 10/BOX SDL1314E 13.5F X 35CM HEMO-CATH® ST 10/BOX CATHETER ONLY SL15C 11.5F X 15CM HEMO-CATH® ST 10/BOX SL20C 11.5F X 20CM HEMO-CATH® ST 10/BOX SL24C 11.5F X 24CM HEMO-CATH® ST 10/BOX 8F BASIC SET CONTAINS: (1) Catheter (1) Dilator (1) Introducer Needle (2) End Caps (1) Guidewire (1) Catheter Clip (1) Adhesive Wound Dressing (1) 10cc Syringe 11F & 13.5F BASIC SET CONTAINS: (1) Catheter w/ Stylet (1) Dilator (1) Introducer Needle (2) End Caps (1) Guidewire (1) Catheter Clip CATHETER ONLY SET CONTAINS: (1) Catheter w/ Stylet (1) Catheter Clip (2) End Caps Material Silicone Tip Design Tapered Tip French Sizes 8F, 11.5F, 13.5F Configuration Straight Hollow Fast Track Stylet Silicone Hemo-Cath® Angled Arterial Tip Double “D” Internal Lumen Design HEMO-CATH® ST Refer to the Table of Contents for Important Risk Information regarding this device. 8
SHORT TERM DUO-FLOW® Material Polyurethane Tip Design Tapered Tip French Sizes 9F, 11.5F Configurations Straight, Pre-Curved, IJ Tapered Tip Coaxial Internal Lumen Design Raulerson IJ Refer to the Table of Contents for Important Risk Information regarding this device. CATHETER ONLY XTP114CT 11.5F X 12CM DUO-FLOW®, STRAIGHT 5/BOX XTP116CT 11.5F X 15CM DUO-FLOW®, STRAIGHT 5/BOX XTP118CT 11.5F X 20CM DUO-FLOW®, STRAIGHT 5/BOX XTP119CT 11.5F X 24CM DUO-FLOW®, STRAIGHT 5/BOX XTP94IJC 9F X 12CM DUO-FLOW®, IJ 5/BOX XTP96IJC 9F X 15CM DUO-FLOW®, IJ 5/BOX XTP98IJC 9F X 20CM DUO-FLOW®, IJ 5/BOX XTP114IJC 11.5F X 12CM, DUO-FLOW®, IJ 5/BOX XTP116IJC 11.5F X 15CM DUO-FLOW®, IJ 5/BOX XTP118IJC 11.5F X 20CM DUO-FLOW®, IJ 5/BOX BASIC SET XTP94MT 9F X 12CM DUO-FLOW®, STRAIGHT 5/BOX XTP96MT 9F X 15CM DUO-FLOW®, STRAIGHT 5/BOX XTP98MT 9F X 20CM DUO-FLOW®, STRAIGHT 5/BOX XTP114MTE 11.5F X 12CM DUO-FLOW®, STRAIGHT 5/BOX XTP116MTE 11.5F X 15CM DUO-FLOW®, STRAIGHT 5/BOX XTP118MTE 11.5F X 20CM DUO-FLOW®, STRAIGHT 5/BOX XTP119MTE 11.5F X 24CM DUO-FLOW®, STRAIGHT 5/BOX XTP114IJS-2 11.5F X 12CM DUO-FLOW®, PRE-CURVED 5/BOX XTP116IJS-2 11.5F X 15CM DUO-FLOW®, PRE-CURVED 5/BOX XTP118IJS-2 11.5F X 20CM DUO-FLOW®, PRE-CURVED 5/BOX XTP94IJS 9F X 12CM DUO-FLOW®, IJ 5/BOX XTP96IJS 9F X 15CM DUO-FLOW®, IJ 5/BOX XTP98IJS 9F X 20CM DUO-FLOW®, IJ 5/BOX XTP114IJSE 11.5F X 12CM, DUO-FLOW®, IJ 5/BOX XTP115IJSE 11.5F X 13.5CM, DUO-FLOW®, IJ 5/BOX XTP116IJSE 11.5F X 15CM DUO-FLOW®, IJ 5/BOX XTP118IJSE 11.5F X 20CM DUO-FLOW®, IJ 5/BOX CATHETER ONLY SET CONTENTS: (1) Catheter (1) Dilator (2) End Caps BASIC SET CONTENTS: (1) Catheter (1) Introducer Needle (1) Guidewire (1) Dilator (1) Scalpel* (1) Adhesive Wound Dressing (2) End Caps *9F IJ Only 9
SHORT TERM 13F BASIC SET CONTAINS: (1) Catheter (1) Dilator (1) Guidewire (1) Introducer Needle (2) End Caps 13F BASIC SET DFST136MTE 13F X 15CM DUO-FLOW® III, STRAIGHT 5/BOX DFST137MTE 13F X 17.5CM DUO-FLOW® III, STRAIGHT 5/BOX DFST138MTE 13F X 20CM DUO-FLOW® III, STRAIGHT 5/BOX DFST1310MTE 13F X 25CM DUO-FLOW® III, STRAIGHT 5/BOX DFST136CEE 13F X 15CM DUO-FLOW® III, CURVED EXTENSIONS 5/BOX DFST137CEE 13F X 17.5CM DUO-FLOW® III, CURVED EXTENSIONS 5/BOX DFST138CEE 13F X 20CM DUO-FLOW® III, CURVED EXTENSIONS 5/BOX DFST1310CEE 13F X 25CM DUO-FLOW® III, CURVED EXTENSIONS 5/BOX Material Polyurethane Tip Design Step Tip French Sizes 13F Configurations Hollow Stylet Patient Centric Curved Extensions 13F Lumen Size DUO-FLOW® III Double “D” Internal Lumen Design Straight, Curved Extensions Refer to the Table of Contents for Important Risk Information regarding this device. 10
SHORT TERM 7F & 9F BASIC SET CONTAINS: (1) Catheter (1) Dilator (1) Guidewire (1) Adhesive Wound Dressing (1) Introducer Needle (2) End Caps 11.5F BASIC SET CONTAINS: (1) Catheter (1) Dilator (1) Guidewire (1) Adhesive Wound Dressing (1) Introducer Needle (2) End Caps BASIC SET T73M 7F X 7CM DUO-FLOW® SOFT-LINE®, STRAIGHT 10/BOX T74M 7F X 10CM DUO-FLOW® SOFT-LINE®, STRAIGHT 10/BOX T94M 9F X 12CM DUO-FLOW® SOFT-LINE®, STRAIGHT 10/BOX T96M 9F X 15CM DUO-FLOW® SOFT-LINE®, STRAIGHT 10/BOX T98M 9F X 20CM DUO-FLOW® SOFT-LINE®, STRAIGHT 10/BOX T114ME 11.5F X 12CM DUO-FLOW® SOFT-LINE®, STRAIGHT 10/BOX T116ME 11.5F X 15CM DUO-FLOW® SOFT-LINE®, STRAIGHT 10/BOX T118ME 11.5F X 20CM DUO-FLOW® SOFT-LINE®, STRAIGHT 10/BOX T119M 11.5F X 24CM DUO-FLOW® SOFT-LINE®, STRAIGHT 10/BOX T114IJS-2 11.5F X 12CM DUO-FLOW® SOFT-LINE®, PRE-CURVED 10/BOX T116IJS-2 11.5F X 15CM DUO-FLOW® SOFT-LINE®, PRE-CURVED 10/BOX T118IJS-2 11.5F X 20CM DUO-FLOW® SOFT-LINE®, PRE-CURVED 10/BOX T116IJS-2E. 11.5F X 15CM DUO-FLOW® SOFT-LINE®, PRE-CURVED 10/BOX T118IJS-2E. 11.5F X 20CM DUO-FLOW® SOFT-LINE®, PRE-CURVED 10/BOX Configurations Straight, Pre-Curved Soft Polyurethane Tapered Tip 360° Arterial Ports Coaxial Internal Lumen Design DUO-FLOW® SOFT-LINE® Material Polyurethane Tip Design Tapered Tip French Sizes 7F, 9F, 11.5F Refer to the Table of Contents for Important Risk Information regarding this device. 11
SHORT TERM DUO-FLOW® SIDE X SIDE CATHETER ONLY CONTAINS: (1) Catheter (2) End Cap BASIC SET CONTAINS: (1) Catheter (1) Introducer Needle (1) Guidewire (1) Dilator (1) Adhesive Wound Dressing (2) End Cap CATHETER ONLY XTP114CT= 11F X 12CM DUO-FLOW® SIDE X SIDE CATHETER ONLY, STRAIGHT 10/BOX XTP116CT= 11F X 15CM DUO-FLOW® SIDE X SIDE CATHETER ONLY, STRAIGHT 10/BOX XTP118CT= 11F X 20CM DUO-FLOW® SIDE X SIDE CATHETER ONLY, STRAIGHT 10/BOX XTP114IJC= 11F X 12CM IJ DUO-FLOW® SIDE X SIDE CATHETER ONLY, CURVED EXTENSIONS 10/BOX XTP116IJC= 11F X 15CM IJ DUO-FLOW® SIDE X SIDE CATHETER ONLY, CURVED EXTENSIONS 10/BOX XTP118IJC= 11F X 20CM IJ DUO-FLOW® SIDE X SIDE CATHETER ONLY, CURVED EXTENSIONS 10/BOX BASIC SET XTP94MT= 9F X 12CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP96MT= 9F X 15CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP98MT= 9F X 20CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP94IJS= 9F X 12CM IJ DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP96IJS= 9F X 15CM IJ DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP114MT= 11F X 12CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP116MT= 11F X 15CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP118MT= 11F X 20CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP119MT= 11F X 24CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP114IJS= 11F X 12CM IJ DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP115IJS= 11F X 13.5CM IJ DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP116IJS= 11F X 15CM IJ DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP118IJS= 11F X 20CM IJ DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP125MTA 12F X 13CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP126MTA 12F X 15CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP128MTA 12F X 20CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP129MTA 12F X 24CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP125IJSA 12F X 13CM DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP126IJSA 12F X 15CM DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP128IJSA 12F X 20CM DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP129IJSA 12F X 24CM DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP126MT=* 12F X 15CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP128MT=* 12F X 20CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP129MT= 12F X 24CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP125IJS= 12F X 13CM IJ DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP126IJS= 12F X 15CM IJ DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP128IJS= 12F X 20CM IJ DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP145MTA 14F X 13CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP146MTA 14F X 15CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP148MTA 14F X 20CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP149MTA 14F X 24CM DUO-FLOW® SIDE X SIDE BASIC SET, STRAIGHT 10/BOX XTP145IJSA 14F X 13CM DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP146IJSA 14F X 15CM DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP148IJSA 14F X 20CM DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX XTP149IJSA 14F X 24CM DUO-FLOW® SIDE X SIDE BASIC SET, CURVED EXTENSIONS 10/BOX * Contains 5CC Syringe Double “D” Internal Lumen Design Tapered Tip Five Large Arterial Holes Material Polyurethane Tip Design Tapered Tip French Sizes 9F, 11F, 12F Configurations Straight, Curved Extensions Refer to the Table of Contents for Important Risk Information regarding this device. 12
SHORT TERM DUO-FLOW® 400XL BASIC SET DFXL146MTE 14F X 15CM DUO-FLOW® 400XL BASIC SET, STRAIGHT 10/BOX DFXL148MTE 14F X 20CM DUO-FLOW® 400XL BASIC SET, STRAIGHT 10/BOX DFXL149MTE 14F X 24CM DUO-FLOW® 400XL BASIC SET, STRAIGHT 10/BOX DFXL144IJSE 14F X 12CM DUO-FLOW® 400XL BASIC SET, PRE-CURVED 10/BOX DFXL146IJSE 14F X 15CM DUO-FLOW® 400XL BASIC SET, PRE-CURVED 10/BOX DFXL148IJSE 14F X 20CM DUO-FLOW® 400XL BASIC SET, PRE-CURVED 10/BOX DFXL149IJSE 14F X 24CM DUO-FLOW® 400XL BASIC SET, PRE-CURVED 10/BOX BASIC SET CONTAINS: (1) Catheter (1) Dilator (1) Guidewire (1) Introducer Needle (2) End Caps 360° Arterial Ports Coaxial Internal Lumen Design Tapered Tip Material Polyurethane Tip Design Tapered Tip French Size 14F Configurations Straight, Pre-Curved Refer to the Table of Contents for Important Risk Information regarding this device. 13
SHORT TERM FREE-FLOW® ST BASIC SET CONTAINS: (1) Catheter w/ Stylet (3) Dilators (1) Guidewire (1) Introducer Needle (2) End Caps STRAIGHT MFFS1215S 12.5F X 15CM FREE-FLOW® W/ STYLET, STRAIGHT 5/BOX MFFS1220S 12.5F X 20CM FREE-FLOW® W/ STYLET, STRAIGHT 5/BOX MFFS1224S 12.5F X 24CM FREE-FLOW® W/ STYLET, STRAIGHT 5/BOX IJ MFFS1212IJ 12.5F X 12CM IJ FREE-FLOW® W/ STYLET 5/BOX MFFS1215IJ 12.5F X 15CM IJ FREE-FLOW® W/ STYLET 5/BOX MFFS1220IJ 12.5F X 20CM IJ FREE-FLOW® W/ STYLET 5/BOX IJ WITH TWO WINGS MFFS1212IJ-2 12.5F X 12CM IJ FREE-FLOW® W/ STYLET AND 2 SUTURE WINGS 5/BOX MFFS1215IJ-2 12.5F X 15CM IJ FREE-FLOW® W/ STYLET AND 2 SUTURE WINGS 5/BOX MFFS1220IJ-2 12.5F X 20CM IJ FREE-FLOW® W/ STYLET AND 2 SUTURE WINGS 5/BOX STRAIGHT MFFS1515S 15.5F X 15CM FREE-FLOW® W/ STYLET, STRAIGHT 5/BOX MFFS1520S 15.5F X 20CM FREE-FLOW® W/ STYLET, STRAIGHT 5/BOX MFFS1524S 15.5F X 24CM FREE-FLOW® W/ STYLET, STRAIGHT 5/BOX IJ MFFS1512IJ 15.5F X 12CM IJ FREE-FLOW® W/ STYLET CATHETER SET 5/BOX MFFS1515IJ 15.5F X 15CM IJ FREE-FLOW® W/ STYLET CATHETER SET 5/BOX MFFS1520IJ 15.5F X 20CM IJ FREE-FLOW® W/ STYLET CATHETER SET 5/BOX Pre-Loaded stylet Rotating Suture Wing Open Tip Material Polyurethane Tip Design Coaxial French Sizes 12.5F, 15.5F Lumen Design 360° Coaxial Configurations Straight, IJ Coaxial Internal Lumen Design Refer to the Table of Contents for Important Risk Information regarding this device. 14
SHORT TERM CATHETER ONLY CONTAINS: (1) Catheter (1) Dilator (1) Attachable Suture Wing (3) End Caps (1) Patient ID Card (1) Patient Chart Sticker BASIC SET CONTAINS: (1) Catheter (1) Introducer Needle (1) Guidewire (1) Dilator (1) Attachable Suture Wing (3) End Caps (1) Patient ID Card (1) Patient Chart Sticker BASIC SET ME CONTAINS: (1) Catheter (1) Introducer Needle (1) Guidewire (1) Dilator (1) Scalpel (1) Adehesive Wound Dressing (1) Attachable Suture Wing (3) End Caps (1) Patient ID Card (1) Patient Chart Sticker CATHETER ONLY AS01135120E. 13.5F X 12CM TRIO-CT® CATHETER ONLY 10/BOX AS01135150E. 13.5F X 15CM TRIO-CT® CATHETER ONLY 10/BOX AS01135200E. 13.5F X 20CM TRIO-CT® CATHETER ONLY 10/BOX AS01135240E. 13.5F X 24CM TRIO-CT® CATHETER ONLY 10/BOX AS01135300E. 13.5F X 30CM TRIO-CT® CATHETER ONLY 10/BOX BASIC SET AS01135121E. 13.5F X 12CM TRIO-CT® BASIC SET 5/BOX AS01135151E. 13.5F X 15CM TRIO-CT® BASIC SET 5/BOX AS01135201E. 13.5F X 20CM TRIO-CT® BASIC SET 5/BOX AS01135241E. 13.5F X 24CM TRIO-CT® BASIC SET 5/BOX AS01135301E. 13.5F X 30CM TRIO-CT® BASIC SET 5/BOX BASIC SET ME AS01135121ME 13.5F X 12CM TRIO-CT® BASIC SET 5/BOX AS01135151ME 13.5F X 15CM TRIO-CT® BASIC SET 5/BOX AS01135201ME 13.5F X 20CM TRIO-CT® BASIC SET 5/BOX AS01135241ME 13.5F X 24CM TRIO-CT® BASIC SET 5/BOX AS01135301ME 13.5F X 30CM TRIO-CT® BASIC SET 5/BOX Material Polyurethane Tip Design Tapered Tip French Size 13.5F Configuration Straight Triple Internal Lumen Design TRIO-CT® Refer to the Table of Contents for Important Risk Information regarding this device. 15
SHORT TERM T-3® CT CT CATHETER ONLY CONTAINS: (1) Catheter (3) Dilators (1) Valved Peelable Introducer (1) Patient ID Card (3) End Caps CT BASIC SET CONTAINS: (1) Catheter (3) Dilators (1) Scalpel (1) Valved Peelable Introducer (1) Guidewire (1) Adhesive Wound Dressing (1) 2-0 Silk Suture (1) Patient ID Card (3) End Caps (1) Introducer Needle CT CATHETER ONLY MC013541 15.5F X 15CM T-3® CT, STRAIGHT 5/BOX MC013542 15.5F X 20CM T-3® CT, STRAIGHT 5/BOX MC013543 15.5F X 24CM T-3® CT, STRAIGHT 5/BOX MC013544 15.5F X 28CM T-3® CT, STRAIGHT 5/BOX MC013545 15.5F X 32CM T-3® CT, STRAIGHT 5/BOX CT BASIC SET MC013501 15.5F X 15CM T-3® CT, STRAIGHT 5/BOX MC013502 15.5F X 20CM T-3® CT, STRAIGHT 5/BOX MC013503 15.5F X 24CM T-3® CT, STRAIGHT 5/BOX MC013504 15.5F X 28CM T-3® CT, STRAIGHT 5/BOX MC013505 15.5F X 32CM T-3® CT, STRAIGHT 5/BOX Step Tip Design & 90° Arterial Lumen Large Lumen Size CT Injectable 15.5F Lumen 90º Degree Triple Internal Lumen Design Material Polyurethane Tip Design Step Tip French Size 15.5F Configuration Straight Refer to the Table of Contents for Important Risk Information regarding this device. 16
SHORT TERM BASIC SET CONTAINS: (1) Catheter (1) Dilator (1) Guidewire (1) Introducer Needle (3) End Caps BASIC SET XTP3114MTE 11.5F X 12CM STRAIGHT TRI-FLOW CATHETER SET 10/BOX XTP3116MTE 11.5F X 15CM STRAIGHT TRI-FLOW CATHETER SET 10/BOX XTP3118MTE 11.5F X 20CM STRAIGHT TRI-FLOW CATHETER SET 10/BOX XTP3119MTE 11.5F X 24CM STRAIGHT TRI-FLOW CATHETER SET 10/BOX BASIC SET - CURVED EXTENSIONS XTP3116IJSE 11.5F X 15CM CE TRI-FLOW CATHETER SET 10/BOX XTP3118IJSE 11.5F X 20CM CE TRI-FLOW CATHETER SET 10/BOX 11.5F Lumen Triple Lumen Tapered Tip Triple Internal Lumen Design Material Polyurethane Tip Design Tapered Tip French Size 11.5F Configurations Straight, Curved Extensions TRI-FLOW Refer to the Table of Contents for Important Risk Information regarding this device. 17
SHORT TERM FEMORAL Material Polyurethane Tip Design Tapered Tip French Sizes 7F, 8.5F, 9F Configurations Single Lumen, Straight Material Polyurethane Tip Design Tapered Tip French Size 8F Configurations Single Lumen, Straight, Pre-Curved CATHETER ONLY CONTAINS: (1) Catheter (1|2) End Cap(s) (1) “Y” Hub* *MCF6 Only BASIC SET CONTAINS: (1) Catheter (1|2) End Cap(s) (1) “Y” Hub* (1) Introducer Needle (1) Guidewire *MCFK60 Only CATHETER ONLY MCF64E 6.5F X 13.3CM FEMORAL CATHETER, STRAIGHT 10/BOX MCF64 7F X 13.5CM FEMORAL CATHETER, STRAIGHT 10/BOX MCF55 8.5F X 14CM FEMORAL CATHETER, STRAIGHT 10/BOX MCF6 8.5F X 15CM FEMORAL CATHETER, STRAIGHT 10/BOX MCF10 8.5F X 25CM FEMORAL CATHETER, STRAIGHT 10/BOX BASIC SET MCFK64 7F X 13.5CM FEMORAL CATHETER, STRAIGHT 10/BOX MCFK100PS 7F X 25CM FEMORAL CATHETER, STRAIGHT 10/BOX MCFK60 8.5F X 15CM FEMORAL CATHETER, STRAIGHT 10/BOX MCFK100 8.5F X 25CM FEMORAL CATHETER, STRAIGHT 10/BOX MCFK550 9F X 14CM FEMORAL CATHETER, STRAIGHT 10/BOX CATHETER ONLY SET CONTENTS: (1) Catheter w/Stylet (1) Removable “Y” Adaptor (1) Injection Cap (1) Patient I.D. Card BASIC SET CONTAINS: (1) Catheter w/ Stylet (1) Removable “Y” Adaptor* (1|2) End Cap(s) (1) Introducer Needle (1) Guidewire (1) Adhesive Wound Dressing CATHETER ONLY MCY306PS 8F X 15CM SUBCLAVIAN CATHETER, WITH REMOVABLE "Y" HUB 10/BOX MCY308PS 8F X 20CM SUBCLAVIAN CATHETER, WITH REMOVABLE "Y" HUB 10/BOX BASIC SET MCYK306PSE* 8F X 15CM SUBCLAVIAN CATHETER, WITH REMOVABLE “Y” HUB 10/BOX MCYK308PSE* 8F X 20CM SUBCLAVIAN CATHETER, WITH REMOVABLE “Y” HUB 10/BOX MCB304K 8F X 12CM SINGLE LUMEN CATHETER KIT, PRE-CURVED 10/BOX MCB306K 8F X 15CM SINGLE LUMEN CATHETER KIT, PRE-CURVED 10/BOX MCB308K 8F X 20CM SINGLE LUMEN CATHETER KIT, PRE-CURVED 10/BOX SUBCLAVIAN Useful in over-the-wire and over-the-needle insertions Multiple Configurations Available in double or single lumen designs. Rotating Suture Wing Removable “Y” Adapter And pre-loaded stylet. Refer to the Table of Contents for Important Risk Information regarding this device. Refer to the Table of Contents for Important Risk Information regarding this device. 18
SHORT TERM
Pro-PICC® Vascu-PICC® Vascu-PICC® TL Vascu-PICC® TLS Valved Pro-PICC® Valved Vascu-PICC® PERIPHERALLY INSERTED CENTRAL CATHETERS IMPORTANT RISK INFORMATION PRO-PICC® Indications for Use: The Pro-PICC® CT catheter is indicated for shor t or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter. Contraindications: The presence of device related infection, bacteremia, or septicemia is known or suspected. The patient’s body size is insufficient to accommodate the size of the implanted device. The patient is known or is suspected to be allergic to materials contained in the device. There has been past irradiation of prospective inser tion site. There have been previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site. There are local tissue factors that may prevent proper device stabilization and/or access. VASCU-PICC® / VASCU-PICC® TL Indications for Use: The Peripherally Inser ted Central Vein Access Catheters are designed for Long or Shor t- Term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring. This catheter may be inser ted via the basilic, cephalic, or median cubital vein. Contraindications: This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels. The presence of skin related problems around the inser tion site (infection, phlebitis, scars, etc.). The presence of device related bacteremia or septicemia. History of mastectomy on inser tion side. Previous history of venous/subclavian thrombosis or vascular surgical procedures at inser tion site. Fever of unknown origin. The patient's body size is insufficient to accommodate the size of the implanted device. The patient is known or is suspected to be allergic to materials contained in the device. Past irradiation of prospective inser tion site. Local tissue factors will prevent proper device stabilization and/or access. VASCU-PICC® TLS Indications for Use: The 1.9F and 2.6F Peripherally Inser ted Central Vein Access Catheters are indicated for shor t or long term access to the central venous system via peripheral inser tion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy. Recommended inser tion sites are the median cubital vein of the elbow or the basilic vein. The long saphenous veins of the ankle may also be used. This catheter is not suitable for inser tion through non-superficial veins. Contraindications: This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels. The presence of skin related problems around the inser tion site (infection, phlebitis, scars, etc.). The presence of device related bacteremia or septicemia. Previous history of venous/subclavian thrombosis or vascular surgical procedures at inser tion site. Fever of unknown origin. The patient's body size is insufficient to accommodate the size of the implanted device. The patient is known or is suspected to be allergic to materials contained in the device. Past irradiation of prospective inser tion site. Local tissue factors will prevent proper device stabilization and/or access. VALVED PRO-PICC® Indications for Use: The Pro-PICC® CT catheter with valve technology is indicated for shor t or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter. Contraindications: The presence of device related infection, bacteremia, or septicemia is known or suspected. The patient’s body size is insufficient to accommodate the size of the implanted device. The patient is known or is suspected to be allergic to materials contained in the device. There has been past irradiation of prospective inser tion site. There have been previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site. There are local tissue factors that may prevent proper device stabilization and/or access. Refer to Instructions for Use provided with the product for complete instructions, warnings, precautions, and contraindications. Observe all instructions for use prior to using products. Failure to do so may result in patient complications. PICCs
PICCs PRO-PICC® French Sizes 3F, 4F, 5F, 6F Lengths 55cm, 60cm Injection Rating 5cc/sec @300psi* Lumens Single, Double, Triple Power Injectable Capable of CT injections up to 5cc/sec at 300 psi for diagnostic imaging.* *Except 3F Pro-PICC® Refer to the Table of Contents for Important Risk Information regarding this device. 22 PICCs
PICCs PRO-PICC® CATHETER ONLY MR17033100 3F X 55CM PRO-PICC®, SINGLE LUMEN EACH MR17034100 4F X 55CM PRO-PICC®, SINGLE LUMEN EACH MR17035100 5F X 60CM PRO-PICC®, SINGLE LUMEN EACH MR17035200 5F X 55CM PRO-PICC®, DOUBLE LUMEN EACH BASIC SET MR17033101 3F X 55CM PRO-PICC®, SINGLE LUMEN EACH MR17034101 4F X 55CM PRO-PICC®, SINGLE LUMEN EACH MR17035101 5F X 60CM PRO-PICC®, SINGLE LUMEN EACH MR17035201 5F X 55CM PRO-PICC®, DOUBLE LUMEN EACH MR17036201 6F X 60CM PRO-PICC®, DOUBLE LUMEN EACH MR17036301 6F X 60CM PRO-PICC®, TRIPLE LUMEN EACH CUT DOWN VERSION SAFETY MRCTP41024 4F X 55CM PRO-PICC®, SINGLE LUMEN EACH MRCTP51024 5F X 60CM PRO-PICC®, SINGLE LUMEN EACH MRCTP52024 5F X 55CM PRO-PICC®, DOUBLE LUMEN EACH MRCTP62024 6F X 60CM PRO-PICC®, DOUBLE LUMEN EACH MRCTP63024 6F X 60CM PRO-PICC®, TRIPLE LUMEN EACH CUT DOWN VERSION NON SAFETY MRCTP41028 4F X 55CM PRO-PICC®, SINGLE LUMEN EACH MRCTP51028 5F X 60CM PRO-PICC®, SINGLE LUMEN EACH MRCTP52028 5F X 55CM PRO-PICC®, DOUBLE LUMEN EACH MRCTP62028 6F X 60CM PRO-PICC®, DOUBLE LUMEN EACH NURSING KIT MR17033105 3F X 55CM PRO-PICC®, SINGLE LUMEN EACH MR17034105 4F X 55CM PRO-PICC®, SINGLE LUMEN EACH MR17035105 5F X 60CM PRO-PICC®, SINGLE LUMEN EACH MR17035205 5F X 55CM PRO-PICC®, DOUBLE LUMEN EACH MR17036205 6F X 60CM PRO-PICC®, DOUBLE LUMEN EACH MR17036305 6F X 60CM PRO-PICC®, TRIPLE LUMEN EACH LONG WIRE SET MR17033102 3F X 55CM PRO-PICC®, SINGLE LUMEN EACH MR17034102 4F X 55CM PRO-PICC®, SINGLE LUMEN EACH MR17035102 5F X 60CM PRO-PICC®, SINGLE LUMEN EACH MR17035202 5F X 55CM PRO-PICC®, DOUBLE LUMEN EACH MR17036202 6F X 60CM PRO-PICC®, DOUBLE LUMEN EACH MR17036302 6F X 60CM PRO-PICC®, TRIPLE LUMEN EACH CATHETER ONLY CONTAINS: (1) PICC w/ Stylet (1|2) Needle Free Valve(s) (1) Catheter Securement Device (1) Patient Information Pack (1) Patient Chart Sticker (1) Patient ID Card BASIC SET CONTAINS: (1) PICC w/ Stylet (1) Peelable Sheath Introducer (1) Mini Scalpel (1) Guidewire (1) 10cc Syringe (1) Tape Measure (1) Introducer Needle (1|2|3) Needle Free Valve(s) (1) Catheter Securement Device (1) Patient Information Pack (1) Patient Chart Sticker (1) Patient ID Card BASIC SET w/ FLUSHABLE STYLET CONTAINS: (1) PICC w/ Flushable Stylet (1) Peelable Sheath Introducer (1) Mini Scalpel (1) Guidewire (1) 10cc Syringe (1) Tape Measure (1) Introducer Needle (1|2|3) Needle Free Valve(s) (1) Catheter Securement Device (1) Patient Information Pack (1) Patient Chart Sticker (1) Patient ID Card LONG WIRE SET CONTAINS: (1) PICC (1) Peelable Sheath Introducer (1) Mini Scalpel (1) Guidewire (1) 10cc Syringe (1) Tape Measure (1) Introducer Needle (1|2|3) Needle Free Valve(s) (1) Catheter Securement Device (1) Patient Information Pack (1) Patient Chart Sticker (1) Patient ID Card NURSING KIT CONTAINS: (1) PICC w/ Stylet (1) Peelable Sheath Introducer (1) Safety Scalpel (1) Guidewire (1) 10cc Syringe (1) Tape Measure (1) Safety Introducer Needle (1|2|3) Needle Free Valve(s) (1) Latex-Free Tourniquet (1) Catheter Securement Device (1) Patient Information Pack (1) Patient Chart Sticker (1) Patient ID Card CUT DOWN VERSION SAFETY CONTAINS: (1) PICC w/ Stylet (1) Peelable Sheath Introducer (1) Safety Introducer Needle (1) Guidewire (1) Safety Scalpel (1) Tape Measure (1) Catheter Securement Device CUT DOWN VERSION NON SAFETY CONTAINS: (1) PICC w/ Stylet (1) Peelable Sheath Introducer (1) Introducer Needle (1) Guidewire (1) Mini Scalpel (1) Tape Measure (1) Catheter Securement Device BASIC SET WITH FLUSHABLE STYLET MR17034111 4F X 55CM PRO-PICC®, SINGLE LUMEN EACH MR17035111 5F X 60CM PRO-PICC®, SINGLE LUMEN EACH MR17035211 5F X 55CM PRO-PICC®, DOUBLE LUMEN EACH MR17036311 6F X 60CM PRO-PICC®, TRIPLE LUMEN EACH Refer to the Table of Contents for Important Risk Information regarding this device. 23
PICCs VASCU-PICC® French Sizes 3F, 4F, 5F, 6F Length 60cm Lumens Single, Double CATHETER ONLY MR17013100 3F X 60CM VASCU-PICC®, SINGLE LUMEN EACH MR17014100 4F X 60CM VASCU-PICC®, SINGLE LUMEN EACH MR17014200 4F X 60CM VASCU-PICC®, DOUBLE LUMEN EACH MR17015200 5F X 60CM VASCU-PICC®, DOUBLE LUMEN EACH MR17016200 6F X 60CM VASCU-PICC®, DOUBLE LUMEN EACH BASIC SET MR17013101 3F X 60CM VASCU-PICC®, SINGLE LUMEN EACH MR17014101 4F X 60CM VASCU-PICC®, SINGLE LUMEN EACH MR17015101 5F X 60CM VASCU-PICC®, SINGLE LUMEN EACH MR17014201 4F X 60CM VASCU-PICC®, DOUBLE LUMEN EACH MR17015201 5F X 60CM VASCU-PICC®, DOUBLE LUMEN EACH MR17016201 6F X 60CM VASCU-PICC®, DOUBLE LUMEN EACH LONG WIRE SET MR17014102 4F X 60CM VASCU-PICC®, SINGLE LUMEN EACH MR17015202 5F X 60CM VASCU-PICC®, DOUBLE LUMEN EACH NURSING KIT MR17013105 3F X 60CM VASCU-PICC®, SINGLE LUMEN EACH MR17014105 4F X 60CM VASCU-PICC®, SINGLE LUMEN EACH MR17015105 5F X 60CM VASCU-PICC®, SINGLE LUMEN EACH MR17014205 4F X 60CM VASCU-PICC®, DOUBLE LUMEN EACH MR17015205 5F X 60CM VASCU-PICC®, DOUBLE LUMEN EACH Reverse Taper Lumen Design Depth Marks CATHETER ONLY CONTAINS: (1) PICC w/ Stylet (1|2) Needle Free Valve(s) (1) Catheter Securement Device (1) Patient Information Pack (1) Patient Chart Sticker (1) Vascu-PICC® IFU BASIC SET CONTAINS: (1) PICC w/ Stylet (1) Peelable Sheath Introducer (1) Mini Scalpel (1) Guidewire (1) 10cc Syringe (1) Tape Measure (1) Introducer Needle (1|2) Needle Free Valve(s) (1) Catheter Securement Device (1) Patient Information Pack (1) Patient Chart Sticker LONG WIRE SET CONTAINS: (1) PICC (1) Peelable Sheath Introducer (1) Mini Scalpel (1) Guidewire (1) 10cc Syringe (1) Tape Measure (1) Introducer Needle (1|2) Needle Free Valve(s) (1) Catheter Securement Device (1) Patient Information Pack (1) Patient Chart Sticker NURSING KIT CONTAINS: (1) PICC w/ Stylet (1) Peelable Sheath Introducer (1) Safety Scalpel (1) Guidewire (1) 10cc Syringe (1) Tape Measure (1) Safety Introducer Needle (1|2) Needle Free Valve(s) (1) Latex-Free Tourniquet (1) Catheter Securement Device (1) Patient Information Pack (1) Patient Chart Sticker Refer to the Table of Contents for Important Risk Information regarding this device. OTN SET VP3S-MNS 3F X 60CM SINGLE VASCU-PICC® W/ OTN INTRODUCER SET EACH VP5S-MNS 5F X 60CM SINGLE VASCU-PICC® W/ OTN INTRODUCER SET EACH VP4D-MNS 4F X 60CM DUAL VASCU-PICC® W/ OTN INTRODUCER SET EACH VP5D-MNS 5F X 60CM DUAL VASCU-PICC® W/ OTN INTRODUCER SET EACH OTN SET CONTAINS: (1) Vascu-PICC® TLS (1) Peelable Sheath Introducer (1) Guidewire (1) Tape Measure (1) 10cc Syringe (1|2) Needle Free Valve(s) (1) Catheter Securement Device (1) Patient Chart Sticker (1) Patient Information Pack 24
PICCs VASCU-PICC® TL CATHETER ONLY MR81013100 3F X 60CM VASCU-PICC® TL, SINGLE LUMEN EACH MR81014100 4F X 60CM VASCU-PICC® TL, SINGLE LUMEN EACH MR81014200 4F X 60CM VASCU-PICC® TL, DOUBLE LUMEN EACH BASIC SET MR81013101 3F X 60CM VASCU-PICC® TL, SINGLE LUMEN EACH MR81014101 4F X 60CM VASCU-PICC® TL, SINGLE LUMEN EACH MR81015101 5F X 60CM VASCU-PICC® TL, SINGLE LUMEN EACH MR81014201 4F X 60CM VASCU-PICC® TL, DOUBLE LUMEN EACH MR81015201 5F X 60CM VASCU-PICC® TL, DOUBLE LUMEN EACH CATHETER ONLY CONTAINS: (1) Vascu-PICC® TL w/ Stylet (1|2) Needle Free Valve(s) (1) Catheter Securement Device (1) Patient Information Pack (1) Patient Chart Sticker BASIC SET CONTAINS: (1) Vascu-PICC® TL w/ Stylet (1) Introducer Needle (1) Peelable Sheath Introducer (1) 10cc Syringe (1) Guidewire (1) Mini Scalpel (1|2) Needle Free Valve(s) (1) Tape Measure (1) Catheter Securement Device (1) Patient Information Pack (1) Patient Chart Sticker French Sizes 3F, 4F, 5F Length 60cm Lumens Single, Double Taperless Lumen Design Depth Marks Refer to the Table of Contents for Important Risk Information regarding this device. 25
PICCs VASCU-PICC® TLS French Sizes 1.9F, 2.6F Lengths 20cm, 50cm Lumens Single, Double Taperless Lumen Design CATHETER ONLY MR17011100 1.9F X 50CM VASCU-PICC® SV, SINGLE LUMEN EACH MR17012600 2.6F X 50CM VASCU-PICC® SV, DOUBLE LUMEN EACH BASIC SET WITH OTN MR17011121 1.9F X 20CM VASCU-PICC® TLS, SINGLE LUMEN EACH MR17011101 1.9F X 50CM VASCU-PICC® TLS, SINGLE LUMEN EACH MR17012621 2.6F X 20CM VASCU-PICC® TLS, DOUBLE LUMEN EACH MR17012601 2.6F X 50CM VASCU-PICC® TLS, DOUBLE LUMEN EACH CATHETER ONLY CONTAINS: (1) Vascu-PICC® TLS w/ Preloaded Stylet (1|2) Needle Free Valve(s) (1) Catheter Securement Device (1) Patient Information Pack (1) Patient Chart Sticker BASIC SET WITH OTN CONTAINS: (1) Vascu-PICC® TLS w/ Preloaded Stylet (1) Peelable Sheath Introducer (1) Latex Free Tourniquet (1) Tape Measure (10) 2" x 2" Gauze (1) 10cc Syringe (1|2) Needle Free Valve(s) (1) Catheter Securement Device (1) Patient Chart Sticker Indicated for Pediatric Use Refer to the Table of Contents for Important Risk Information regarding this device. 26
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