Identity
- Trade Name
- Geratherm Baby ColorChoice Digital Thermometer FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Digital thermometer with backlight, 10 second readings, beeps when ready, flextip, jumbo display, waterproof, auto shut-off, dual scale provided with protective case. FDA UDI
- Model / Reference
- Retail Pink Digital Thermometer w-backlight FDA UDI
- Description
- Digital thermometer with backlight, 10 second readings, beeps when ready, flextip, jumbo display, waterproof, auto shut-off, dual scale provided with protective case. FDA UDI
Identifiers
- Catalog Number
- 30060 FDA UDI
- Primary DI / UDI-DI
- 00614801300605 FDA UDI
- 510(k) Number
- K070028 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 Baby ColorChoice 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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Also classified as Intermittent electronic patient thermometer.
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Cleared under the same submission
K070028 also covers:
- Actherm — Dongguan Actherm Medical Corp.
- Actherm — Dongguan Actherm Medical Corp.
- Actherm — Dongguan Actherm Medical Corp.
- Actherm — Dongguan Actherm Medical Corp.
- Actherm — Dongguan Actherm Medical Corp.
- Actherm — Dongguan Actherm Medical Corp.
- Actherm — Dongguan Actherm Medical Corp.
- Actherm — Dongguan Actherm Medical Corp.
- Actherm — Dongguan Actherm Medical Corp.
- Actherm — Dongguan Actherm Medical Corp.
- Actherm — Dongguan Actherm Medical Corp.
- Actherm — Dongguan Actherm Medical Corp.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- R.g. Enterprises (u.s.a.), Inc.
Sources (1)
- FDA UDI 7f3103cd-26e8-441f-a573-d06a3930c720 36 fields · synced Jun 8, 2026