Catalog Number

AKG STMP50

Brand Name

AlcoMate

Version/Model Number

AlcoMate Standard Breathalyzer Mouthpieces 50 Count

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 05, 2020

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DJZ

Product Code Name

Devices, Breath Trapping, Alcohol

Public Device Record Key

46cb0db7-4fc3-44fd-8592-ace96f974339

Public Version Date

March 26, 2021

Public Version Number

3

DI Record Publish Date

August 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-