WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301

FDA UDI

Class II (US FDA UDI)

by Golden Smart Home Technology Corp.

Identity

Trade Name: WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301 FDA UDI
Generic Name: Infrared patient thermometer, ear FDA UDI
Device Name: The WowGoHealth IR Ear Thermometer with Bluetooth (Model GSH-BTS301) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages. FDA UDI
Model / Reference: GSH-BTS301 FDA UDI
Description: The WowGoHealth IR Ear Thermometer with Bluetooth (Model GSH-BTS301) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages. FDA UDI

Identifiers

Primary DI / UDI-DI: 04719878123013 FDA UDI
510(k) Number: K110559 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 70 Gram FDA UDI
Length — 158.5 Millimeter FDA UDI
Width — 44.5 Millimeter FDA UDI
Height — 54.3 Millimeter FDA UDI

Category: Infrared patient thermometer, ear

WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301 by Golden Smart Home Technology Corp. — Class II — FDA UDI — listed in FDA GUDID

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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 5c1b1fee-4ed8-4959-b6a6-28802963cd8c 36 fields · synced May 31, 2026