Identity
- Trade Name
- Famidoc FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- This clinical digital thermometer is intended for human body temperature, including oral,underarm and rectal temperature. This thermometer is suitable for people at different ages, including infants, children and adults. FDA UDI
- Model / Reference
- FDTH-V0-4 FDA UDI
- Description
- This clinical digital thermometer is intended for human body temperature, including oral,underarm and rectal temperature. This thermometer is suitable for people at different ages, including infants, children and adults. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818218022048 FDA UDI
- 510(k) Number
- K072641 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
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
Famidoc by Famidoc Technology Company Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K072641 also covers:
- Famidoc — FAMIDOC USA, INC.
- Famidoc — FAMIDOC USA, INC.
- Famidoc — FAMIDOC USA, INC.
- Famidoc — FAMIDOC USA, INC.
- Famidoc — FAMIDOC USA, INC.
- Famidoc — FAMIDOC USA, INC.
- Famidoc — Famidoc Technology Company Limited
- Famidoc — Famidoc Technology Company Limited
- Famidoc — Famidoc Technology Company Limited
- Famidoc — Famidoc Technology Company Limited
- Famidoc — Famidoc Technology Company Limited
- Famidoc — Famidoc Technology Company Limited
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
- Famidoc Technology Company Limited
Sources (1)
- FDA UDI 12a72b3b-ac99-40a5-9c2f-ed4ae0813f89 34 fields · synced May 30, 2026