Catalog Number

-

Brand Name

Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*16cm(Straight)

Version/Model Number

H2Y-FH-2125

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102833,K102833,K102833

Product Code

MPB

Product Code Name

Catheter, Hemodialysis, Non-Implanted

Public Device Record Key

06a5c98b-21a0-4a79-b129-11166fa9555a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

26938634491674

Quantity per Package

40

Contains DI Package

16938634491677

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-