Catalog Number

165000

Brand Name

Mouthseal, Disposable, White Thermoplastic Rubber

Version/Model Number

Mouthseal, White Thermoplastic - 165000

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

c3388cfa-e53a-4b27-bc98-4449c0696aad

Public Version Date

March 23, 2020

Public Version Number

2

DI Record Publish Date

January 13, 2020

Package DI Number

00817081024234

Quantity per Package

50

Contains DI Package

00817081024227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-