Disposable Pressure Manometer

FDA UDI

Class II (US FDA UDI)

by D R Burton Healthcare, Llc

Identity

Trade Name: Disposable Pressure Manometer FDA UDI
Generic Name: Airway pressure monitor, non-powered FDA UDI
Device Name: The disposable pressure manometer provides visual indication of airway pressure. FDA UDI
Model / Reference: 1 FDA UDI
Description: The disposable pressure manometer provides visual indication of airway pressure. FDA UDI

Identifiers

Catalog Number: 566 FDA UDI
Primary DI / UDI-DI: 10851232007759 FDA UDI
510(k) Number: K192000 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

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

Yes

FDA UDI

Category: Airway pressure monitor, non-powered

Disposable Pressure Manometer by D R Burton Healthcare, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K192000 also covers:

OxyPAP — D R BURTON HEALTHCARE, LLC

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: D R Burton Healthcare, Llc

Sources (1)

FDA UDI 9997e7cc-d542-4005-a6c9-e1748e5a982e 36 fields · synced Jun 8, 2026