Catalog Number

-

Brand Name

Test Cartridge

Version/Model Number

BG3

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

K151978,K151978,K151978

Product Code

CHL

Product Code Name

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

Public Device Record Key

42f61fb2-4586-4b37-bdca-5aa3dc6ccc24

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

06944413801950

Quantity per Package

25

Contains DI Package

06944413802919

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-