Catalog Number

-

Brand Name

FLEXIBLE MOUTHPIECE

Version/Model Number

1691020

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

6976bdb7-d46f-4d6e-b817-f2cab6adc832

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 12, 2021

Package DI Number

05030267136223

Quantity per Package

10

Contains DI Package

05030267136216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-