Duns Number:119201320
Device Description: The AlcoMate Premium breathalyzer features patented PRISM Technology, which eliminates two The AlcoMate Premium breathalyzer features patented PRISM Technology, which eliminates two fundamental flaws of traditional re-calibration: sensor degradation and the turnaround cycle. The Premium is approved by the US Department of Transportation (DOT) for law enforcement use, and is widely used by both professionals and general consumers concerned with long-term accuracy. The US Navy selected the AlcoMate brand for single-source supply for its ongoing substance testing program.
Catalog Number
AKG AL7000
Brand Name
AlcoMate
Version/Model Number
Premium AL7000
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
-
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
c12129c5-8d45-47be-ad9c-f62a90a78c0a
Public Version Date
March 25, 2021
Public Version Number
2
DI Record Publish Date
August 24, 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 |