Identity
- Trade Name
- Physio Logic Accuflex Digital Thermometer - Red FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Accuflex® single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and make it easy to prevent the spread of contamination among patients. This digital thermometer is easy to use and provides fast readings. Most importantly, Accuflex is reliable and accurate for patients of all ages. Accurate within ± 0.1°C in the 35°C to 42°C range Fast response time: 10 seconds Washable for easy cleaning Gentle-flex tip for patient comfort Auto shut-off feature Memory recall / display of last 30 readings Individually packaged, includes storage case Anti-Bacterial additive Convenient colour codes – blue for oral and red for rectal FDA UDI
- Model / Reference
- 016-629 FDA UDI
- Description
- Accuflex® single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and make it easy to prevent the spread of contamination among patients. This digital thermometer is easy to use and provides fast readings. Most importantly, Accuflex is reliable and accurate for patients of all ages. Accurate within ± 0.1°C in the 35°C to 42°C range Fast response time: 10 seconds Washable for easy cleaning Gentle-flex tip for patient comfort Auto shut-off feature Memory recall / display of last 30 readings Individually packaged, includes storage case Anti-Bacterial additive Convenient colour codes – blue for oral and red for rectal FDA UDI
Identifiers
- Catalog Number
- 016-629 FDA UDI
- Primary DI / UDI-DI
- 00057565166290 FDA UDI
- 510(k) Number
- K163518 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
Yes
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
Physio Logic Accuflex Digital Thermometer - Red by A.M.G. Médicale Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K163518 also covers:
- ACCUFLEXPRO+ ORAL THERMOMETER (BLUE) — A.M.G. Médicale Inc
- ACCUFLEXPRO+ RECTAL THERMOMETER (RED) — A.M.G. Médicale Inc
- PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue) — A.M.G. Médicale Inc
- PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red) — A.M.G. Médicale Inc
- Physio Logic Accuflex Digital Thermometer — A.M.G. Médicale Inc
- PhysioLogic DigiPro+ 30 second Digital Oral Thermometer — A.M.G. Médicale Inc
- Greater Goods — Greater Goods, LLC
- Greater Goods — Greater Goods, LLC
- HEB in Control — H. E. BUTT GROCERY COMPANY
- HEB in Control — H. E. BUTT GROCERY COMPANY
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 5a4a9afc-6c6e-422f-803d-e511b87a30df 35 fields · synced Jun 6, 2026