Identity
- Trade Name
- FDK FDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Device Name
- FDK DIGITAL THERMOMETER FDA UDI
- Model / Reference
- BT-A11CN FDA UDI
- Description
- FDK DIGITAL THERMOMETER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859020006017 FDA UDI
- 510(k) Number
- K101387 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- General-purpose patient temperature probe, single-use 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
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: General-purpose patient temperature probe, single-use
Fdk by Fudakang Industrial Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K101387 also covers:
- ADVOCATE ORAL & RECTAL THERMOMETER — DIABETIC SUPPLY OF SUNCOAST, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- Safety 1st — DOREL JUVENILE GROUP, INC.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
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
- Fudakang Industrial Co., Ltd.
Sources (1)
- FDA UDI c30e21ff-4e5b-46e9-b202-e03321898dbc 34 fields · synced Jun 8, 2026