Catalog Number

-

Brand Name

Global Blood Resources

Version/Model Number

HBBSD2000

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

DTN

Product Code Name

Reservoir, Blood, Cardiopulmonary Bypass

Public Device Record Key

d48727a7-2b83-4e3a-bd23-d23e5b0b7d9c

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

10854438002009

Quantity per Package

5

Contains DI Package

00854438002002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton