Identity
- Trade Name
- Geratherm Colorchoice Oral Digital Thermometer FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- The ColorChoice Oral Digital non-flex tip thermometer is white with blue accent colors around the display window and start button. The temperature measuring range is 90.0°F to 109.0°F. It uses a 1.55V battery with more than 200 hours of continuous use. An audible beep sounds with the peak temperature is reached and the Memory Mode displays the last reading. A battery replacement symbol will appear on the display when the battery is low with an auto shut off feature in 10 minutes. A clear protective case is provided FDA UDI
- Model / Reference
- Oral Digital Thermometer with Blue and White coloring FDA UDI
- Description
- The ColorChoice Oral Digital non-flex tip thermometer is white with blue accent colors around the display window and start button. The temperature measuring range is 90.0°F to 109.0°F. It uses a 1.55V battery with more than 200 hours of continuous use. An audible beep sounds with the peak temperature is reached and the Memory Mode displays the last reading. A battery replacement symbol will appear on the display when the battery is low with an auto shut off feature in 10 minutes. A clear protective case is provided FDA UDI
Identifiers
- Catalog Number
- 30010 FDA UDI
- Primary DI / UDI-DI
- 00614801300100 FDA UDI
- 510(k) Number
- K903590 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
No
FDA UDI
Category: Intermittent electronic patient thermometer
Geratherm Colorchoice Oral Digital Thermometer by R.g. Enterprises (u.s.a.), Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- R.g. Enterprises (u.s.a.), Inc.
Sources (1)
- FDA UDI 2422ce88-40c4-4c6d-a714-77f557ec433b 36 fields · synced May 30, 2026