Puritan Bennett

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Puritan Bennett FDA UDI
Generic Name: Artificial airway tube cuff pressure monitor FDA UDI
Device Name: Cuff Pressure Manager FDA UDI
Model / Reference: 180-03 FDA UDI
Description: Cuff Pressure Manager FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521782495 FDA UDI
FDA Product Code: BSK FDA UDI
GMDN Term: Artificial airway tube cuff pressure monitor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5750 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Artificial airway tube cuff pressure monitor

Puritan Bennett by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Artificial airway tube cuff pressure monitor.

Pylant Monitor — KAL-MED, LLC. · Class II
Cuff Pressure Monitor Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
Cuff Pressure Monitor Assembly — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
Portex — ICU MEDICAL, INC. · Class II
Cuff Pressure Monitor Assembly — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
Puritan Bennett — Covidien LP · Class II

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: Covidien LP

Sources (1)

FDA UDI f1ad6c58-e04b-4ed7-b1fb-58444b68cd37 35 fields · synced May 30, 2026