WowGoHealth Pulse Oximeter GSH601

FDA UDI

Class II (US FDA UDI)

by Golden Smart Home Technology Corp.

Identity

Trade Name: WowGoHealth Pulse Oximeter GSH601 FDA UDI
Generic Name: Pulse oximeter FDA UDI
Device Name: The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter. FDA UDI
Model / Reference: GSH601 FDA UDI
Description: The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter. FDA UDI

Identifiers

Catalog Number: Orange FDA UDI
Primary DI / UDI-DI: 04719878124027 FDA UDI
FDA Product Code: OCH FDA UDI
GMDN Term: Pulse oximeter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Weight — 50 Gram FDA UDI
Height — 58 Millimeter FDA UDI
Width — 34 Millimeter FDA UDI
Depth — 30 Millimeter FDA UDI

Category: Pulse oximeter

WowGoHealth Pulse Oximeter GSH601 by Golden Smart Home Technology Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 d76d7313-e573-4cee-a155-ae54c1229561 36 fields · synced May 30, 2026