Newport

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Newport FDA UDI
Generic Name: Carbon dioxide cuvette, single-use FDA UDI
Device Name: PED/Adult Airway Flow Sensor FDA UDI
Model / Reference: SEN3420A FDA UDI
Description: PED/Adult Airway Flow Sensor FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521774049 FDA UDI
510(k) Number: K111146 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: Carbon dioxide cuvette, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 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

Yes

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: Carbon dioxide cuvette, single-use

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

Similar devices

Also classified as Carbon dioxide cuvette, single-use.

Respiratory Mechanics Combined Flow/CO2 Sensor – Pediatric — Draeger Medical Systems, Inc. · Class II
Airway Adapters — Respironics Novametrix, LLC · Class I
Newport Medical — Newport Medical Instruments · Class II
Disposable CO2 Cuvette paed. — Drägerwerk AG & Co. KGaA · Class II
Respiratory Mechanics Sensor – Neonatal — Draeger Medical Systems, Inc. · Class II
Airway Adapters — Respironics Novametrix, LLC · Class I
Respiratory Mechanics Combined Flow/CO2 Sensor – Adult/pediatric — Draeger Medical Systems, Inc. · Class II
Respiratory Mechanics Combined Flow/CO2 Sensor – Neonatal — Draeger Medical Systems, Inc. · Class II

Cleared under the same submission

K111146 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: Covidien LP

Sources (1)

FDA UDI 861239c0-c1ac-440a-973e-32e6123d1e5d 35 fields · synced Jun 8, 2026