Kenorex

FDA UDI

Class II (US FDA UDI)

by Kentron Health Care, Inc.

Identity

Trade Name: KENOREX FDA UDI
Generic Name: Airway pressure monitor, non-powered FDA UDI
Device Name: RESUSCITATOR MANOMETER 0-60 CMS WATER 30 MM ID FDA UDI
Model / Reference: 779504 FDA UDI
Description: RESUSCITATOR MANOMETER 0-60 CMS WATER 30 MM ID FDA UDI

Identifiers

Catalog Number: 779504 FDA UDI
Primary DI / UDI-DI: 10852244007362 FDA UDI
510(k) Number: K140370 FDA UDI
FDA Product Code: CAP FDA UDI
GMDN Term: Airway pressure monitor, non-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2600 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

MRI Safety

MR Safe FDA UDI

Category: Airway pressure monitor, non-powered

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

Similar devices

Also classified as Airway pressure monitor, non-powered.

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AincA® — Anesthesia Associates, Inc. · Class II
RESUSCITATION ACCESSORY — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
BE 149-1 Gauge Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
AincA® — Anesthesia Associates, Inc. · Class II

Cleared under the same submission

K140370 also covers:

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 9790c7e0-e735-4cd5-905c-5fecd8918519 36 fields · synced May 30, 2026