Allied Medical LLC

FDA UDI

Class II (US FDA UDI)

by Allied Medical LLC

Identity

Trade Name: Allied Medical LLC FDA UDI
Generic Name: Airway pressure monitor, non-powered FDA UDI
Device Name: Manometer FDA UDI
Model / Reference: 890060 FDA UDI
Description: Manometer FDA UDI

Identifiers

Catalog Number: 890060 FDA UDI
Primary DI / UDI-DI: 00026072011287 FDA UDI
510(k) Number: K003497 FDA UDI
FDA Product Code: BXR FDA UDI
GMDN Term: Airway pressure monitor, non-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1780 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Airway pressure monitor, non-powered

Allied Medical LLC by Allied Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

K003497 also covers:

DPM — Engineered Medical Systems, LLC
Disposable Pressure Manometer — Engineered Medical Systems, LLC
DPM — Pulmodyne Inc.
DPM — Pulmodyne Inc.

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: Allied Medical LLC

Sources (1)

FDA UDI 2a96a1f6-482d-4028-a256-7e609196c5fc 35 fields · synced May 30, 2026