Disposable Pressure ManometerSingle Patient Use

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name: Disposable Pressure ManometerSingle Patient Use FDA UDI
Generic Name: Airway pressure monitor, non-powered FDA UDI
Device Name: Manometer - 20PCS/BOX, 12BOXES/T30BOX US FDA UDI
Model / Reference: 322004000 FDA UDI
Description: Manometer - 20PCS/BOX, 12BOXES/T30BOX US FDA UDI

Identifiers

Catalog Number: 322004000 FDA UDI
Primary DI / UDI-DI: 05707480032372 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 6.4 Gram FDA UDI
Length — 55 Millimeter FDA UDI
Outer Diameter — 22 Millimeter FDA UDI

Category: Airway pressure monitor, non-powered

Disposable Pressure ManometerSingle Patient Use by Ambu A/S — 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: Ambu A/S

Sources (1)

FDA UDI 1d2f6b3d-710c-4930-8937-6a60b6b8258e 38 fields · synced May 30, 2026