Catalog Number

-

Brand Name

AE II BAN

Version/Model Number

Filtered Mouthpiece, cs/50

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BYW

Product Code Name

Device, Rebreathing

Public Device Record Key

6da4fca0-9cbb-4645-a9af-798f409440ce

Public Version Date

September 09, 2021

Public Version Number

7

DI Record Publish Date

July 25, 2017

Package DI Number

50604351600503

Quantity per Package

50

Contains DI Package

00604351600508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-