KenTeK

FDA UDI

Class II (US FDA UDI)

by Kentron Health Care, Inc.

Identity

Trade Name: KenTeK FDA UDI
Generic Name: Pulse oximeter FDA UDI
Device Name: KenTeK FINGER PULSE OXIMETER WITH OLED SCREEN, MEASURE BLOOD OXYGEN SATURATION LEVEL AND PULSE RATE, PR WAVEFORM DISPLAY, LOW BATTERY INDICATOR, AUTOMATIC POWER OFF, FOUR DIRECTIONS DISPLAY. FDA UDI
Model / Reference: KT-2000 FDA UDI
Description: KenTeK FINGER PULSE OXIMETER WITH OLED SCREEN, MEASURE BLOOD OXYGEN SATURATION LEVEL AND PULSE RATE, PR WAVEFORM DISPLAY, LOW BATTERY INDICATOR, AUTOMATIC POWER OFF, FOUR DIRECTIONS DISPLAY. FDA UDI

Identifiers

Catalog Number: KT-2000 FDA UDI
Primary DI / UDI-DI: 00810003751171 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

MRI Safety

MR Unsafe FDA UDI

Category: Pulse oximeter

KenTeK by Kentron Health Care, Inc. — 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: Kentron Health Care, Inc.

Sources (1)

FDA UDI 16d242dd-963d-4ea0-b49e-a8825dd89945 35 fields · synced May 30, 2026