Catalog Number

CH8000-019

Brand Name

V. Mueller

Version/Model Number

CH8000-019

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2021

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"

-

For Single-Use

-

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

-

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

a85b502b-808f-42f1-8f31-6df5b442a10e

Public Version Date

March 04, 2022

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-