Disposable CO2 Cuvette paed.

FDA UDI

Class II (US FDA UDI)

by Drägerwerk AG & Co. KGaA

Identity

Trade Name: Disposable CO2 Cuvette paed. FDA UDI
Generic Name: Carbon dioxide cuvette, single-use FDA UDI
Model / Reference: MP01063 FDA UDI

Identifiers

Primary DI / UDI-DI: 04048675421597 FDA UDI
510(k) Number: K100941 FDA UDI
FDA Product Code: CCK FDA UDI
GMDN Term: Carbon dioxide cuvette, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1400 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

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

Yes

FDA UDI

Category: Carbon dioxide cuvette, single-use

Disposable CO2 Cuvette paed. by Drägerwerk AG & Co. KGaA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Newport — Covidien LP · Class II
Airway Adapters — Respironics Novametrix, LLC · Class I
Respiratory Mechanics Combined Flow/CO2 Sensor – Adult/pediatric — Draeger Medical Systems, Inc. · Class II

Cleared under the same submission

K100941 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: Drägerwerk AG & Co. KGaA

Sources (1)

FDA UDI 722fac65-4ac5-4c60-8771-9f4d5221f79d 33 fields · synced Jun 6, 2026