Address:Unit 1 Galway Business PArk,Galway,IE
Device Description : The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, steppe The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped 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, Coring Scalpel 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
Device Class :
Duns Number: 896253098
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, steppe The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped 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, Coring Scalpel 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
Device Class :
Duns Number: 896253098
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, steppe The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped 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, Coring Scalpel 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
Device Class : 2
Duns Number: 896253098
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, steppe The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped 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, Coring Scalpel 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
Device Class : 2
Duns Number: 896253098
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, steppe The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped 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, Coring Scalpel 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
Device Class : 2
Duns Number: 896253098
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, steppe The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped 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, Coring Scalpel 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
Device Class : 2
Duns Number: 896253098
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lum The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lumen, split 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, 17Fr 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
Device Class :
Duns Number: 896253098
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lum The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lumen, split 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, 17Fr 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.
Device Class :
Duns Number: 896253098
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lum The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lumen, split 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, 17Fr 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
Device Class : 2
Duns Number: 896253098
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lum The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lumen, split 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, 17Fr 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
Device Class :
Duns Number: 896253098
Premarket Exempt : No
Prescription Use : Yes