Catalog Number

-

Brand Name

Global Blood Resources

Version/Model Number

TS3 Sentara

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2019

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

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Public Device Record Key

3b38734d-a736-4309-b834-f819f96bef6a

Public Version Date

November 18, 2019

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

10854438002023

Quantity per Package

5

Contains DI Package

00008544382026

Package Discontinue Date

November 15, 2019

Package Status

Not in Commercial Distribution

Package Type

carton