Duns Number:119201320
Device Description: AlcoMate AL4000 FUEL CELL Coin-Operated Vending-Type Breathalyzer with Pre-Calibrated Repl AlcoMate AL4000 FUEL CELL Coin-Operated Vending-Type Breathalyzer with Pre-Calibrated Replaceable Sensor Technology. Only FUEL CELL sensor modules will work with this device. Important: the device is available in coin-operation mode only (device image may not be accurate.
Catalog Number
AKG-AL4000
Brand Name
AlcoMate
Version/Model Number
AL4000
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
74b29409-e96a-46f3-9227-141ef596c209
Public Version Date
March 25, 2021
Public Version Number
2
DI Record Publish Date
October 06, 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 |