Identity
- Trade Name
- AlcoMate FDA UDI
- Generic Name
- Alcohol breath analyser FDA UDI
- Device Name
- AlcoMate Prestige AL6000 is the original breath tester that introduced pre-calibrated replaceable sensor module technology to the market. Pre-calibrated replaceable sensor modules eliminate the need for traditional mail-back calibration service that is required of all other typical breathalyzers. FDA UDI
- Model / Reference
- Prestige AL6000 FDA UDI
- Description
- AlcoMate Prestige AL6000 is the original breath tester that introduced pre-calibrated replaceable sensor module technology to the market. Pre-calibrated replaceable sensor modules eliminate the need for traditional mail-back calibration service that is required of all other typical breathalyzers. FDA UDI
Identifiers
- Catalog Number
- AKG AL6000 FDA UDI
- Primary DI / UDI-DI
- 00853464001041 FDA UDI
- FDA Product Code
- OIC FDA UDIDJZ FDA UDI
- GMDN Term
- Alcohol breath analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3040 FDA UDI862.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alcohol breath analyser
AlcoMate by Ak Globaltech Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ak Globaltech Corp
Sources (1)
- FDA UDI 4c20ac31-78ac-440c-8b5d-7bae1f7a9978 36 fields · synced May 30, 2026