Catalog Number

-

Brand Name

Haemonetics

Version/Model Number

736-21

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

BK860040,BK860040

Product Code

KSR

Product Code Name

CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS

Public Device Record Key

cfbfd21e-7603-47b9-831c-6c8dbaecf805

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

April 17, 2017

Package DI Number

30887691002954

Quantity per Package

2

Contains DI Package

20887691002957

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-