Duns Number:119201320
Device Description: AlcoMate Core Model AL6000-L Alcohol Tester is a good choice for consumers who would prefe AlcoMate Core Model AL6000-L Alcohol Tester is a good choice for consumers who would prefer price savings over the advantages of pre-calibrated sensor module technology. Aside from the sensor technology, the AlcoMate® Core breathalyzer gives you all of the other features of the AlcoMate® Prestige, with easy-to-use one-button operation.
Catalog Number
AKG AL6000-L
Brand Name
AlcoMate
Version/Model Number
AL6000-L
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
d50d7df2-d404-47e2-a49f-e7498c2db381
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
August 27, 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 |