Duns Number:119201320
Device Description: AlcoMate TS600 is an evidential breathalyzer (EBT) with advanced fuel cell technology. TS6 AlcoMate TS600 is an evidential breathalyzer (EBT) with advanced fuel cell technology. TS600 is a highly-upgraded professional breathalyzer for measuring alcohol in human breath. Test results can be stored on TS600 or printed out the data through wired or wireless (optional) connecting with mobile printer.
Catalog Number
AKG TS600
Brand Name
AlcoMate
Version/Model Number
TS600
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
bb0a8a80-31f0-47fc-803b-44e506ccff71
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 |