Identity
- Trade Name
- AlcoMate FDA UDI
- Generic Name
- Alcohol breath analyser FDA UDI
- Device Name
- AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from other breathalyzer mouthpieces, our one-way flow technology provides the most accurate results. For the best results, please use genuine AlcoMate Breathalyzer Mouthpieces. Fits for all AlcoMate brand breathalyzers, Revo TS200, Premium AL7000, Prestige AL6000, AccuCell AL9000, Core. FDA UDI
- Model / Reference
- STDMP20 FDA UDI
- Description
- AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from other breathalyzer mouthpieces, our one-way flow technology provides the most accurate results. For the best results, please use genuine AlcoMate Breathalyzer Mouthpieces. Fits for all AlcoMate brand breathalyzers, Revo TS200, Premium AL7000, Prestige AL6000, AccuCell AL9000, Core. FDA UDI
Identifiers
- Catalog Number
- AKG-STDMP20 FDA UDI
- Primary DI / UDI-DI
- 00853464001430 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
Yes
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
No
FDA UDI
Expiration Date
No
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 0ffeb83e-a671-487b-bc06-1f807bd4c0e8 35 fields · synced Jun 8, 2026