Catalog Number

GWT-000-30

Brand Name

Hemostasis Valve Adapter

Version/Model Number

GWT-000-30

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

-

Product Code

DTL

Product Code Name

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Public Device Record Key

e101c048-c1cc-4325-b822-ef0447cd1ffc

Public Version Date

March 05, 2020

Public Version Number

3

DI Record Publish Date

February 06, 2018

Package DI Number

20841268107230

Quantity per Package

100

Contains DI Package

10841268107233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box