Maquet Cardiohelp

FDA UDI

Class II (US FDA UDI)

by Maquet Cardiopulmonary AG

Identity

Trade Name: MAQUET CARDIOHELP FDA UDI
Generic Name: Extracorporeal blood gas/pH monitor FDA UDI
Device Name: The Venous Probe is to measure SO2, Hb, HCT and venous temperature as an accessory for CARDIOHELP. The CARDIOHELP System is a miniaturized and light medical perfusion system. The general function of the CARDIOHELP System is to drive, to control, to monitor and to protocol the extra corporeal circulation (ECC). The CARDIOHELP System acts as a drive unit for a disposable tubing set including at least pump and oxygenator. FDA UDI
Model / Reference: Venous Probe FDA UDI
Description: The Venous Probe is to measure SO2, Hb, HCT and venous temperature as an accessory for CARDIOHELP. The CARDIOHELP System is a miniaturized and light medical perfusion system. The general function of the CARDIOHELP System is to drive, to control, to monitor and to protocol the extra corporeal circulation (ECC). The CARDIOHELP System acts as a drive unit for a disposable tubing set including at least pump and oxygenator. FDA UDI

Identifiers

Catalog Number: 70104.8803 FDA UDI
Primary DI / UDI-DI: 04037691641041 FDA UDI
510(k) Number: K102726 FDA UDI
FDA Product Code: DTQ FDA UDI
GMDN Term: Extracorporeal blood gas/pH monitor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4220 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

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

Dimensions & Sizes

Size: Weight — 0.208 Kilogram FDA UDI
Total Volume — 2.569 Liter FDA UDI

Category: Extracorporeal blood gas/pH monitor

Maquet Cardiohelp by Maquet Cardiopulmonary AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K102726 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: Maquet Cardiopulmonary AG

Sources (1)

FDA UDI fa120699-eb8f-4fc6-9101-3a9cc67357dd 36 fields · synced Jun 8, 2026