Catalog Number

CO2SL055-8MM

Brand Name

NA

Version/Model Number

CO2SL055-8MM

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

K131410,K131410

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

0dbf3c76-160a-4128-92b0-7755c2cd1cda

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-