Identity
- Trade Name
- iProvèn FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Dual mode thermometer FDA UDI
- Model / Reference
- DMT-489-new FDA UDI
- Description
- Dual mode thermometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719481721459 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 Masena Invest B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131243 also covers:
- Fever Thermometer — BETTER BASICS, INC.
- Fever therometer — BETTER BASICS, INC.
- Dagamma — DAGAMMA INC.
- Infrared Forehead Thermometer — Dynarex Corp.
- ProHT — Inland Products, Inc.
- MedOne — MEDONE LLC
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
K172795 also covers:
- Wireless Infrared Thermometer — CLOUD DX INC.
- KONQUEST — KONQUEST GROUP INC
- MOBI — MOBI TECHNOLOGIES, INC.
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
- iProvèn — Masena Invest B.V.
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
- Masena Invest B.V.
Sources (1)
- FDA UDI 1575cefa-e81e-4aea-a0ec-d185050be49d 34 fields · synced May 30, 2026