Catalog Number

162323

Brand Name

Mouthpiece, Disposable, 1.0" OD

Version/Model Number

Mouthpiece, Disposable, 1.0" OD - 162323

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

d61b8328-f8b8-406c-b6e7-8d44b21e150d

Public Version Date

April 08, 2020

Public Version Number

1

DI Record Publish Date

March 31, 2020

Package DI Number

00817081026191

Quantity per Package

500

Contains DI Package

00817081026184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-