Duns Number:119201320
Device Description: The AlcoMate Revo breathalyzer combines the revolutionary innovation of PRISM technology w The AlcoMate Revo breathalyzer combines the revolutionary innovation of PRISM technology with state-of-the-art fuel-cell precision to offer the most reliable, convenient and accurate commercial breathalyzer available on the market. PRISM Technology, Advanced Fuel-Cell Alcohol Sensor, Sleek, Lightweight Design, Single-source Selection by the US Navy and Marine Corps.
Catalog Number
AKG TS200
Brand Name
AlcoMate
Version/Model Number
AlcoMate Revo TS200
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
19014ebb-c21b-4233-a555-25f2aad2ec98
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 |