Catalog Number

00044000130

Brand Name

GEM ChemSTAT CVP 3

Version/Model Number

00044000130

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

-

Product Code

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Public Device Record Key

5cfc1b3b-a41c-487d-852d-7b0588cfdc5f

Public Version Date

July 13, 2021

Public Version Number

3

DI Record Publish Date

June 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-