Fdk

FDA UDI

Class II (US FDA UDI)

by Fudakang Industrial Co., Ltd.

Identity

Trade Name: FDK FDA UDI
Generic Name: Pulse oximeter FDA UDI
Device Name: Speaking Blood Oxygen Fingertip Pulse Oximeter FDA UDI
Model / Reference: FT-E688 Plus FDA UDI
Description: Speaking Blood Oxygen Fingertip Pulse Oximeter FDA UDI

Identifiers

Primary DI / UDI-DI: 00859020006390 FDA UDI
FDA Product Code: DQA 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulse oximeter

Fdk by Fudakang Industrial Co., Ltd. — 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: Fudakang Industrial Co., Ltd.

Sources (1)

FDA UDI 17acb4ae-eec9-4024-bee5-f09d3a43b086 33 fields · synced May 30, 2026