Duns Number:119201320
Device Description: The AccuCell provides superior, high-capacity testing, but without the PRISM Technology av The AccuCell provides superior, high-capacity testing, but without the PRISM Technology available with the Revo. However, if the optional PC USB Kit is also purchased, the software can store test results from the AccuCell onto a Windows computer. Note that results can be stored ONLY while the device is connected to a PC running the optional MAX20 software at the time of testing.
Catalog Number
AKG AL9000
Brand Name
AlcoMate
Version/Model Number
AccuCell AL9000
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
9c086a58-7e92-4e20-a0b6-f60b1f28d395
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 |