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WowGoHealth Infrared Ear & Forehead Thermometer GSH-351
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- WowGoHealth Infrared Ear & Forehead Thermometer GSH-351 FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- The WowGoHealth Infrared Ear & Forehead Thermometer (Model GSH-351) is an infrared thermometer intended for the intermittent measurement of human body temperature from the auditory canal and from the forehead for people of all ages used in the home setting. The non-contact thermometer detects infrared heat from the forehead at distance of about 1-2cm. FDA UDI
- Model / Reference
- GSH-351 FDA UDI
- Description
- The WowGoHealth Infrared Ear & Forehead Thermometer (Model GSH-351) is an infrared thermometer intended for the intermittent measurement of human body temperature from the auditory canal and from the forehead for people of all ages used in the home setting. The non-contact thermometer detects infrared heat from the forehead at distance of about 1-2cm. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719878123518 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, ear 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 66 Gram FDA UDILength — 152 Millimeter FDA UDIWidth — 52 Millimeter FDA UDIHeight — 36 Millimeter FDA UDI
Category: Infrared patient thermometer, ear
WowGoHealth Infrared Ear & Forehead Thermometer GSH-351 by Golden Smart Home Technology Corp. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Infrared patient thermometer, ear.
- Famidoc — Famidoc Technology Company Limited · Class II
- Braun — KAZ USA, INC. · Class II
- Clever Choice — SIMPLE DIAGNOSTICS · Class II
- Braun — KAZ USA, INC. · Class II
- Bytech — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. · Class II
- Easy@Home Infrared Ear Thermometers — EASY HEALTHCARE CORPORATION · Class II
- Clever Choice — SIMPLE DIAGNOSTICS · Class II
- CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class II
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
- Golden Smart Home Technology Corp.
Sources (1)
- FDA UDI f23443a6-94df-465f-9a01-0f905a393177 36 fields · synced May 30, 2026