Duns Number:119201320
Device Description: The AlcoMate TS100 offers advanced fuel-cell alcohol sensing technology for maximum precis The AlcoMate TS100 offers advanced fuel-cell alcohol sensing technology for maximum precision in a sleek, lightweight form factor for ultra-portability. The TS100 allows you to carry a breathalyzer in even the smallest of compartments and gives you access to discreet testing with no sacrifice in accuracy.
Catalog Number
AKG TS100
Brand Name
AlcoMate
Version/Model Number
TS100
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
63889fda-863f-47af-8e63-a855abb7188f
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 |