Catalog Number

32401532

Brand Name

UltraStream Chronic Dialysis Catheter Peel Away Kit

Version/Model Number

32401532

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102043,K102043,K102043

Product Code

MSD

Product Code Name

Catheter, Hemodialysis, Implanted

Public Device Record Key

d123f0fc-2394-4b8f-b2fa-aac2abc03ecb

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

10886333222848

Quantity per Package

1

Contains DI Package

00886333222841

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box