Catalog Number

-

Brand Name

Haemonetics Corporation

Version/Model Number

732-37M

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

BK840010,BK840010

Product Code

KSR

Product Code Name

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

Public Device Record Key

012c5cbd-6894-4c4d-9ea9-56f2e5a1b680

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

March 03, 2017

Package DI Number

30887691002879

Quantity per Package

8

Contains DI Package

20887691002872

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-