NexSite HD Hemodialysis Catheter - The NexSite™ HD, Hemodialysis Catheter for long - MARVAO MEDICAL DEVICES LIMITED

Duns Number:896253098

Device Description: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radi 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 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

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More Product Details

Catalog Number

NEXHD1556002

Brand Name

NexSite HD Hemodialysis Catheter

Version/Model Number

NEXHD1556002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171571,K171571

Product Code Details

Product Code

MSD

Product Code Name

Catheter, Hemodialysis, Implanted

Device Record Status

Public Device Record Key

85d126b9-8598-426f-a148-3706c42630b8

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

January 05, 2018

Additional Identifiers

Package DI Number

05391525640372

Quantity per Package

5

Contains DI Package

05391525640365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MARVAO MEDICAL DEVICES LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8