Catalog Number

164910

Brand Name

Mouthpiece, Disposable, White, Thermoplastic

Version/Model Number

Mouthpiece, White, Thermoplastic - 164910

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

35d5a667-8702-446a-a1eb-44b7fbfb0f32

Public Version Date

March 23, 2020

Public Version Number

2

DI Record Publish Date

January 13, 2020

Package DI Number

00817081024203

Quantity per Package

10

Contains DI Package

00817081024197

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-