Catalog Number

2K8085

Brand Name

AirLife™

Version/Model Number

2K8085

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"

Yes

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

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

f459911e-5fbe-462d-b4c0-179b6ae0338b

Public Version Date

May 11, 2021

Public Version Number

1

DI Record Publish Date

May 03, 2021

Package DI Number

50190752156034

Quantity per Package

10

Contains DI Package

10190752156036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case