Catalog Number

-

Brand Name

Aero-Pro HEPA Light Machine

Version/Model Number

201022

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

d4ddbba4-0fbf-4b9d-95b4-9641e8a23647

Public Version Date

January 24, 2022

Public Version Number

3

DI Record Publish Date

April 24, 2020

Package DI Number

10841470110052

Quantity per Package

50

Contains DI Package

00841470110055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-