NexSite HD Hemodialysis Catheter NEXHDSY1552701

GUDID 05391525640457

The NexSite™ HD, Hemodialysis Catheter for long term use 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, Catheter Stylet and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a sterile pouch so that the tray can be delivered to the sterile field

MARVAO MEDICAL DEVICES LIMITED

Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable Double-lumen haemodialysis catheter, implantable
Primary Device ID05391525640457
NIH Device Record Keya25f7e3c-298d-4877-a88a-36ec525a50c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexSite HD Hemodialysis Catheter
Version Model NumberNEXHDSY1552701
Catalog NumberNEXHDSY1552701
Company DUNS896253098
Company NameMARVAO MEDICAL DEVICES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855 210 0554
Emailinfo@marvaomedical.com
Phone855 210 0554
Emailinfo@marvaomedical.com
Phone855 210 0554
Emailinfo@marvaomedical.com
Phone855 210 0554
Emailinfo@marvaomedical.com
Phone855 210 0554
Emailinfo@marvaomedical.com
Phone855 210 0554
Emailinfo@marvaomedical.com
Phone855 210 0554
Emailinfo@marvaomedical.com
Phone855 210 0554
Emailinfo@marvaomedical.com
Phone855 210 0554
Emailinfo@marvaomedical.com
Phone855 210 0554
Emailinfo@marvaomedical.com

Device Dimensions

Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter
Length27 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105391525640440 [Primary]
GS105391525640457 [Package]
Contains: 05391525640440
Package: Carton with 5 units [5 Units]
In Commercial Distribution

FDA Product Code

MSDCatheter, Hemodialysis, Implanted

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-19
Device Publish Date2018-08-27

On-Brand Devices [NexSite HD Hemodialysis Catheter]

05391525640501The NexSite™ HD , Hemodialysis Catheter for long term use is a dual lumen, symmetric tip radio
05391525640488The NexSite™ HD,Hemodialysis Catheter for long term use is a dual lumen, symmetric tip radiopa
05391525640464The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, symmetric tip radiop
05391525640457The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, symmetric tip radiop
05391525640426The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, symmetric tip radiop
05391525640402The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, symmetric tip radiop
05391525640365The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
05391525640341The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
05391525640327The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
05391525640303The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
05391525640280The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
05391525640266The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
05391525640242The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
05391525640112The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
05391525640099The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
05391525640075The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
05391525640051The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
05391525640020The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
05391525640006The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq

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