Catalog Number

M1038637

Brand Name

AirLife

Version/Model Number

M1038637

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

-

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

9335c8c6-034e-47fe-82a9-53b20dd8724f

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

September 14, 2016

Package DI Number

70885403284429

Quantity per Package

50

Contains DI Package

10885403284427

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack