Catalog Number

164950

Brand Name

Breathbite Mouthpiece, Disposable , Tongue Depressing

Version/Model Number

Breathbite Mouthpiece - 164950

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

BYP

Product Code Name

Mouthpiece, Breathing

Public Device Record Key

d973c8c2-71ec-4a74-b689-145804c26ddd

Public Version Date

September 07, 2021

Public Version Number

1

DI Record Publish Date

August 30, 2021

Package DI Number

00817081027044

Quantity per Package

50

Contains DI Package

00817081027037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-