Catalog Number

-

Brand Name

MOUTHPIECE, 22M

Version/Model Number

1930000

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

63f75993-0aa2-4d15-b3ca-da3d7e4b25e9

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 12, 2021

Package DI Number

05030267004249

Quantity per Package

160

Contains DI Package

05030267056422

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-