Identity
- Trade Name
- Accuflex5 VU Thermometer, from Physio Logic FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Accurate readings in as little as 5 seconds. •Color feverline alert indicates if the reading is normal or if it represents a mild or high fever. •Large, backlit screen displays temperature in °C or °F. •Beeps when reading is complete. •Professional accuracy within 0.1°C (0.2°F). •Waterproof gentle–flex tip for added comfort & safety. •Recalls last reading. •Can be used orally, rectally, under the arm or to take bath water temperature. •Auto shut-off for extended battery life FDA UDI
- Model / Reference
- 016-651 FDA UDI
- Description
- Accurate readings in as little as 5 seconds. •Color feverline alert indicates if the reading is normal or if it represents a mild or high fever. •Large, backlit screen displays temperature in °C or °F. •Beeps when reading is complete. •Professional accuracy within 0.1°C (0.2°F). •Waterproof gentle–flex tip for added comfort & safety. •Recalls last reading. •Can be used orally, rectally, under the arm or to take bath water temperature. •Auto shut-off for extended battery life FDA UDI
Identifiers
- Catalog Number
- 016-651 FDA UDI
- Primary DI / UDI-DI
- 00057565166511 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Intermittent electronic patient thermometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intermittent electronic patient thermometer
Accuflex5 VU Thermometer, from Physio Logic by A.M.G. Médicale Inc — 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
- A.M.G. Médicale Inc
Sources (1)
- FDA UDI 382c4279-ec2f-4216-b5f4-09559c9c34f6 34 fields · synced Jun 8, 2026