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Maquet Cardiohelp

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 701048001

by Maquet Cardiopulmonary AG

Identity

Trade Name
FBS 3/8" x 3/32" L0.9 EUDAMED
MAQUET CARDIOHELP FDA UDI
Generic Name
Cardiopulmonary bypass system air bubble/fluid level detector FDA UDI
Device Name
FBS 3/8" x 3/32" L0.9 EUDAMED
Flow-/bubble sensor for 3/8“ x 3/32“ tubing, length 0.9 m. This bubble sensor is an accessory for CARDIOHELP System as 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. This system is designed for inter- and intra-hospital transportation (transportation (limitations may apply for individual disposables). FDA UDI
Model / Reference
701048001 EUDAMED
FBS 3/8" x 3/32" L0.9 FDA UDI
Description
Flow-/bubble sensor for 3/8“ x 3/32“ tubing, length 0.9 m. This bubble sensor is an accessory for CARDIOHELP System as 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. This system is designed for inter- and intra-hospital transportation (transportation (limitations may apply for individual disposables). FDA UDI

Identifiers

Catalog Number
70104.8001 FDA UDI
Primary DI / UDI-DI
04037691651873 EUDAMEDFDA UDI
Basic UDI-DI
B-04037691651873 EUDAMED
510(k) Number
K102726 FDA UDI
FDA Product Code
DTQ FDA UDI
EMDN Code
Z12050280 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Cardiopulmonary bypass system air bubble/fluid level detector FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
870.4220 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 1.274 Liter FDA UDI
Weight — 0.172 Kilogram FDA UDI

Category: Cardiopulmonary bypass system air bubble/fluid level detector

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

Similar devices

Also classified as Cardiopulmonary bypass system air bubble/fluid level detector.

Cleared under the same submission

K102726 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Maquet Cardiopulmonary AG

Sources (2)

  • FDA UDI 96e1f1ed-c828-4e00-ae9d-86e5caed8dcf 36 fields · synced Jul 25, 2026
  • EUDAMED 9f124203-a286-4885-815e-4781733d37d8 61 fields · synced Jul 25, 2026