Identity
- Trade Name
- Zewa FDA UDI
- Generic Name
- Infrared patient thermometer, ear/skin FDA UDI
- Device Name
- Infrared Thermometer FDA UDI
- Model / Reference
- 11115 FDA UDI
- Description
- Infrared Thermometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00682891111159 FDA UDI
- 510(k) Number
- K172795 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, ear/skin 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infrared patient thermometer, ear/skin
Zewa by Veridian Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infrared patient thermometer, ear/skin.
- CHOSEN Infrared Forehead Thermometer — ABOUND Diagnostics, Inc · Class II
- huangirl Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
- FIGHTECH — Shenzhen Urion Technology Co., Ltd. · Class II
- Infrared Thermometer — Shenzhen Pacom Medical Instruments Co., Ltd. · Class II
- Infrared Thermometer — Shenzhen Jumper Medical Equipment Co., Ltd. · Class II
- MOBI — MOBI TECHNOLOGIES, INC. · Class II
- CONAIR CORPORATION — CONAIR LLC. · Class II
- AlphaMed — Shenzhen Urion Technology Co., Ltd. · Class II
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Veridian Healthcare
Sources (1)
- FDA UDI 5cb20f35-e8ee-4e75-a0be-80c2b570d28c 34 fields · synced Jun 1, 2026