Identity
- Trade Name
- Physio Logic Digiflex 10 Thermometer FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Accurate readings in as little as 10 seconds. •Accurate within 0.2 °F / 0.1 °C •Use orally, rectally or underarm •Gentle-flex tip for added comfort & safety. •Fast 10 second reading* •Beep signals peak temperature •Water resistant for easy cleaning •Automatic shut-off feature •Includes storage case FDA UDI
- Model / Reference
- 016-645 FDA UDI
- Description
- Accurate readings in as little as 10 seconds. •Accurate within 0.2 °F / 0.1 °C •Use orally, rectally or underarm •Gentle-flex tip for added comfort & safety. •Fast 10 second reading* •Beep signals peak temperature •Water resistant for easy cleaning •Automatic shut-off feature •Includes storage case FDA UDI
Identifiers
- Catalog Number
- 016-645 FDA UDI
- Primary DI / UDI-DI
- 00057565166450 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
Physio Logic Digiflex 10 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 c6559d1b-12aa-4ee9-910a-5d9223cddac7 34 fields · synced May 30, 2026