Co2 Analyzer Module

FDA UDI

Class II (US FDA UDI)

by Maquet Critical Care AB

Identity

Trade Name: CO2 ANALYZER MODULE FDA UDI
Generic Name: Neonatal/adult intensive-care ventilator FDA UDI
Model / Reference: 6881766 FDA UDI

Identifiers

Primary DI / UDI-DI: 07325710002889 FDA UDI
510(k) Number: K151814 FDA UDI
K180098 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: Neonatal/adult intensive-care ventilator 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

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

FDA UDI

Category: Neonatal/adult intensive-care ventilator

Co2 Analyzer Module by Maquet Critical Care AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Maquet Critical Care AB

Sources (1)

FDA UDI ebaa7738-2f85-4778-95a1-042e16c510f4 33 fields · synced May 30, 2026