Catalog Number

-

Brand Name

Plastic Mouthpieces (100)

Version/Model Number

Z-5000-2608

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

e556ba64-5260-459c-bb5b-3acf437bd993

Public Version Date

March 23, 2020

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

20857175006078

Quantity per Package

6

Contains DI Package

10857175006071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-