Catalog Number

-

Brand Name

Areo-Pro

Version/Model Number

200302

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

c4883dfa-ab32-4c58-828b-f58ba97a2dc0

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

May 08, 2020

Package DI Number

10841470110366

Quantity per Package

25

Contains DI Package

00841470110369

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-