Kentex

FDA UDI

Class I (US FDA UDI)

by Kentron Health Care, Inc.

Identity

Trade Name: KENTEX FDA UDI
Generic Name: Oxygen quick-connect coupling, female FDA UDI
Device Name: OXYGEN COUPLER OHMEDA STYLE WITH 1/8" CONNECTOR FDA UDI
Model / Reference: 550040 FDA UDI
Description: OXYGEN COUPLER OHMEDA STYLE WITH 1/8" CONNECTOR FDA UDI

Identifiers

Primary DI / UDI-DI: 00810003754684 FDA UDI
FDA Product Code: BZA FDA UDI
GMDN Term: Oxygen quick-connect coupling, female FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5810 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Oxygen quick-connect coupling, female

Kentex by Kentron Health Care, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oxygen quick-connect coupling, female.

PC — Allied Medical LLC · Class I
PC — Allied Medical LLC · Class I
PC — Allied Medical LLC · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I
PC — Allied Medical LLC · Class I
HA, O2, INTL (DISSF X DISSF)15FT — Parker Hannifin Corp. · Class I

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Kentron Health Care, Inc.

Sources (1)

FDA UDI 8355099c-178b-4728-90ad-efabcfc0eb12 33 fields · synced May 30, 2026