Catalog Number

00044000000

Brand Name

GEM Premier ChemSTAT

Version/Model Number

00044000000

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

-

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

K183546,K183549,K183555

Product Code

CHL

Product Code Name

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Public Device Record Key

57e08ca9-d88f-4e67-aaa1-7c3ccfb81bcd

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

June 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-