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The NexSite™ HD, Hemodialysis Symmetric Tip Catheter for long term use is indicated for use in attaining long term vascular access for chronic hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein which should only be used when no other upper extremity or chest wall options are available. Catheters greater than 40cm are indicated for femoral vein insertion.

The NexSite™ HD, Hemodialysis Symmetric Tip Catheter for long term use (19 cm, 23 cm, 37 cm, 31 cm, 35 cm and 55 cm (tip to cuff lengths) is a dual lumen, symmetric tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038" guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field.

The NexSite™ HD, Hemodialysis Step Tip Catheter for long term use (60cm) is indicated for use in attaining long term vascular access for chronic hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate include the subclavian vein which should only be used when no other upper extremity or chest wall options are available. Catheters greater than 40cm are indicated for femoral vein insertion.

NexSite™ HD Hemodialysis Step Tip Catheter for Long Term Use (60cm)

The NexSite HD Hemodialysis Step Tip Catheter for long term use is indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are indicated for femoral vein insertion.

The proposed device, the NexSite HD Hemodialysis Step Tip Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The proposed device is available in the following models below and has a Dacron cuff distal to the bifurcation hub. Models: NexSite HD Hemodialysis Step Tip Catheter for long term use (24cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (28cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (32cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (36cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (40cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (55cm) A Dermal Ingrowth Support Collar (DISC), manufactured from polyurethane and Dacron®. and supplied with the Catheter, is implanted subcutaneously, and is intended to assist with the direction of the catheter. The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, and Luer Caps) that are used to facilitate catheter placement. The NexSite HD Hemodialysis Step Tip Catheter for long term use is provided as a sterile, singleuse device, and is sterilized using a validated ethylene oxide process. It is a blood contact device with greater than 30 days of exposure.

The NexSite HD, Hemodialysis Split Tip Catheter for long term use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are indicated for femoral vein insertion.

NexSite™ HD, Hemodialysis Split Tip Catheter for long term use

The NexSite™ HD, Hemodialysis Catheter for long term use is indicated for use in attaining long term vascular access for chronic hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm long are intended for femoral vein insertion.

The NexSite HD (55 cm), Hemodialysis Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The NexSite HD, Hemodialysis Catheter for long term use is available in a range of lengths up to 55cm. The NexSite HD (55cm) Hemodialysis Catheter is manufactured from polyurethane and has a Dacron cuff distal to the bifurcation junction. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is intended to minimize Catheter movement. The Catheter and DISC are provided with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement. The NexSite HD (55 cm) Hemodialysis Catheter for long term use is provided as a sterile, singleuse device, and is sterilized using a validated ethylene oxide process. The NexSite HD (55 cm) Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.

Indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein.

The Modified NexSite HD Hemodialysis Catheter for long term use is intended for use in attaining long term vascular access for hemodialysis and apheresis. The polyurethane catheter has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is intended to assist with the direction of the catheter. The catheter is provided in three catheter lengths (32cm, 36cm and 40cm). The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement. The Modified NexSite HD, Hemodialysis Catheter for long term use is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process. The Modified NexSite HD Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.

The NexSite HD, Hemodialysis Catheter for long term use is indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein.

The NexSite HD, Hemodialysis Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The polyurethane NexSite HD, Hemodialysis Catheter for long term use is available in two lengths, 24cm and 28cm, and has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is intended to minimize Catheter movement. The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement. The NexSite HD, Hemodialysis Catheter for long term use is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process. The NexSite HD, Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.

The NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter is indicated for long-term access to the Central Venous System. It is designed for administering IV fluids, blood products, drugs, and parenteral nutrition as well as blood withdrawal and power injection of contrast media. The maximum pressure of power injectors used with the NexSite device may not exceed 300psi.

The NexSite 9Fr Dual Lumen Catheter is a long-term central venous catheter. The polyurethane Catheter is 55.5cm in length, and has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Port supplied with the Catheter is implanted subcutaneously, and is intended to minimize Catheter movement. The Catheter and Port are packaged with accessories that are used to facilitate Catheter and Port insertion.