Catalog Number

CAR1090

Brand Name

ClearChem Diagnostics Inc. Carbon Dioxide (CO2)

Version/Model Number

CAR1090

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KHS

Product Code Name

ENZYMATIC, CARBON-DIOXIDE

Public Device Record Key

199f1d2f-9568-4914-918a-3d3665a5a9ce

Public Version Date

June 11, 2018

Public Version Number

2

DI Record Publish Date

April 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-