TCM4 combi module, TCpO2/O2 combi module

FDA UDI

Class II (US FDA UDI)

by Radiometer Medical ApS

Identity

Trade Name: TCM4 combi module, TCpO2/O2 combi module FDA UDI
Generic Name: Transcutaneous blood gas monitoring system FDA UDI
Device Name: TCM4 combi module, TCpO2/O2 combi module FDA UDI
Model / Reference: 902-778 FDA UDI
Description: TCM4 combi module, TCpO2/O2 combi module FDA UDI

Identifiers

Catalog Number: 902-778 FDA UDI
Primary DI / UDI-DI: 05700699027788 FDA UDI
FDA Product Code: LKD FDA UDI
DQA FDA UDI
KLK FDA UDI
LPP FDA UDI
GMDN Term: Transcutaneous blood gas monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2480 FDA UDI
870.2700 FDA UDI
868.2500 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Transcutaneous blood gas monitoring system

TCM4 combi module, TCpO2/O2 combi module by Radiometer Medical ApS — 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: Radiometer Medical ApS

Sources (1)

FDA UDI c7afaefc-832c-4bdf-abc0-a725fa62b010 36 fields · synced Jun 8, 2026