Identity
- Trade Name
- AlcoMate FDA UDI
- Generic Name
- Alcohol breath analyser FDA UDI
- Device Name
- The AlcoMate Premium breathalyzer features patented PRISM Technology, which eliminates two fundamental flaws of traditional re-calibration: sensor degradation and the turnaround cycle. The Premium is approved by the US Department of Transportation (DOT) for law enforcement use, and is widely used by both professionals and general consumers concerned with long-term accuracy. The US Navy selected the AlcoMate brand for single-source supply for its ongoing substance testing program. FDA UDI
- Model / Reference
- Premium AL7000 FDA UDI
- Description
- The AlcoMate Premium breathalyzer features patented PRISM Technology, which eliminates two fundamental flaws of traditional re-calibration: sensor degradation and the turnaround cycle. The Premium is approved by the US Department of Transportation (DOT) for law enforcement use, and is widely used by both professionals and general consumers concerned with long-term accuracy. The US Navy selected the AlcoMate brand for single-source supply for its ongoing substance testing program. FDA UDI
Identifiers
- Catalog Number
- AKG AL7000 FDA UDI
- Primary DI / UDI-DI
- 00853464001102 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 c12129c5-8d45-47be-ad9c-f62a90a78c0a 36 fields · synced Jun 1, 2026