Catalog Number

00024019255

Brand Name

GEM Premier 5000

Version/Model Number

00024019255

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

K160412,K173403,K203790

Product Code

CHL

Product Code Name

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

Public Device Record Key

d143acfd-3198-46f1-aadf-a69f9bce2e11

Public Version Date

September 16, 2022

Public Version Number

8

DI Record Publish Date

March 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-