Identity
- Trade Name
- Physiologic Accuflex Pro+ Digital Thermometer FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- The Accuflex Pro+ Digital Thermometer provides a quick and accurate reading of an individual’s body temperature. It features a comfortable and flexible tip along with beeper and memory functions. It is intended to measure body temperature orally, rectally, or under the arm. Perfect for clinical or home use for people of all ages. FDA UDI
- Model / Reference
- 016-658 FDA UDI
- Description
- The Accuflex Pro+ Digital Thermometer provides a quick and accurate reading of an individual’s body temperature. It features a comfortable and flexible tip along with beeper and memory functions. It is intended to measure body temperature orally, rectally, or under the arm. Perfect for clinical or home use for people of all ages. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00057565166580 FDA UDI
- 510(k) Number
- K183393 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intermittent electronic patient thermometer
Physiologic Accuflex Pro+ Digital Thermometer 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 eb2f4ab5-dcba-4088-a414-5e6f4ccc5db7 34 fields · synced May 31, 2026