Duns Number:119201320
Device Description: AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from other breathalyzer mouthpieces, our one-way flow technology provides the most accurate results. For the best results, please use genuine AlcoMate Breathalyzer Mouthpieces. Fits for all AlcoMate brand breathalyzers, Revo TS200, Premium AL7000, Prestige AL6000, AccuCell AL9000, Core
Catalog Number
AKG INDMP
Brand Name
AlcoMate
Version/Model Number
AlcoMate Individually Wrapped Breathalyzer Mouthpieces
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)
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
0f2762cf-5d58-4566-b10a-daf0763b8eec
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
August 31, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |