Catalog Number

-

Brand Name

Aero-Pro

Version/Model Number

201012

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K013122,K013122,K013122

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

b806880f-800e-46a0-b1b8-597e7b8e4950

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

August 25, 2020

Package DI Number

10841470109810

Quantity per Package

20

Contains DI Package

00841470109813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-