Catalog Number

164901

Brand Name

Mouthpiece, Disposable , White, Thermoplastic

Version/Model Number

Mouthpiece, Disposable , White, Thermoplastic - 164901

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

212f17f3-e16a-45f0-b4ce-a3ade62ab424

Public Version Date

April 10, 2020

Public Version Number

1

DI Record Publish Date

April 02, 2020

Package DI Number

00817081026276

Quantity per Package

450

Contains DI Package

00817081026269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-