Catalog Number

AM-TS-000

Brand Name

BD Blood Pump transfusion set

Version/Model Number

1

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

K983559,K983559

Product Code

FJK

Product Code Name

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Public Device Record Key

75c60092-99ac-4b75-97c9-e639b03ae6eb

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

June 12, 2020

Package DI Number

20704411011856

Quantity per Package

50

Contains DI Package

00704411011852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case