Catalog Number

-

Brand Name

Aero-Sat Filter Compact Straight

Version/Model Number

100802

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

K013122,K013122

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

5136385b-6c7c-4782-8d15-17b4ccc0a622

Public Version Date

April 04, 2022

Public Version Number

1

DI Record Publish Date

March 25, 2022

Package DI Number

10841470110472

Quantity per Package

25

Contains DI Package

00841470110475

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-