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PhysioLogic DigiPro+ 30 second Digital Oral Thermometer
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- PhysioLogic DigiPro+ 30 second Digital Oral Thermometer FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- DigiPro+ ™ 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. What’s more, DigiPro+™ utilizes a “real measurement” technology, which permits read after the beep if a higher temperature is later detected. Accurate within ± 0.1°C in the 35.5°C to 42°C range Displays in Celsius or Fahrenheit Response time: 30 seconds for oral readings Auto shut-off feature Memory recall / display of last reading Individually packaged, includes storage case FDA UDI
- Model / Reference
- 016-625 FDA UDI
- Description
- DigiPro+ ™ 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. What’s more, DigiPro+™ utilizes a “real measurement” technology, which permits read after the beep if a higher temperature is later detected. Accurate within ± 0.1°C in the 35.5°C to 42°C range Displays in Celsius or Fahrenheit Response time: 30 seconds for oral readings Auto shut-off feature Memory recall / display of last reading Individually packaged, includes storage case FDA UDI
Identifiers
- Catalog Number
- 016-625 FDA UDI
- Primary DI / UDI-DI
- 00057565964568 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intermittent electronic patient thermometer
PhysioLogic DigiPro+ 30 second Digital Oral Thermometer by A.M.G. Médicale Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intermittent electronic patient thermometer.
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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
- Physio Logic Accuflex Digital Thermometer - Red — 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 599aaa5b-9ce3-45e1-bd64-ccd60bc53917 35 fields · synced May 30, 2026