Identity
- Trade Name
- iProvèn FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Basal Body Thermometer FDA UDI
- Model / Reference
- BBT-127 FDA UDI
- Description
- Basal Body Thermometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719699636538 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
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
No
FDA UDI
Category: Intermittent electronic patient thermometer
iProvèn by Sevenground Trading B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- iProvèn — Masena Invest B.V. · Class II
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sevenground Trading B.V.
Sources (1)
- FDA UDI 50368a31-b393-4fe2-aebc-fb8bc9272736 35 fields · synced May 30, 2026