Catalog Number

800-0744

Brand Name

GPS® III

Version/Model Number

800-0744

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"

-

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

BK070026

Product Code

KSS

Product Code Name

SUPPLIES, BLOOD-BANK

Public Device Record Key

b6e606c4-7994-44d4-a20a-8c762ca25f7e

Public Version Date

February 05, 2020

Public Version Number

4

DI Record Publish Date

November 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-