Identity
- Trade Name
- Ozeri FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- The Thermometer can display the result in either Fahrenheit or degree Celsius. How to use: Steady and smoothly scroll the wheel either back and fourth or in one direction, so as to travel 12 inches or 30 cm. The scrolling will kinetically charge the device. Continue scroll the wheel until the LCD ON. Position the thermometer at the distance of less than 1 inch for the center of the patients eyebrows. Press and release the measure button. FDA UDI
- Model / Reference
- TH1-W FDA UDI
- Description
- The Thermometer can display the result in either Fahrenheit or degree Celsius. How to use: Steady and smoothly scroll the wheel either back and fourth or in one direction, so as to travel 12 inches or 30 cm. The scrolling will kinetically charge the device. Continue scroll the wheel until the LCD ON. Position the thermometer at the distance of less than 1 inch for the center of the patients eyebrows. Press and release the measure button. FDA UDI
Identifiers
- Catalog Number
- NT1 FDA UDI
- Primary DI / UDI-DI
- 00815817013484 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, ear 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
Yes
FDA UDI
Category: Infrared patient thermometer, ear
Ozeri by Commonpath Llc — 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
- Commonpath Llc
Sources (1)
- FDA UDI 4c1a1dc4-53d9-4e0d-98da-d25d52744f20 35 fields · synced May 30, 2026