Maquet Cardiopulmonary AG

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS (DWF) (5) Console, Heart-Lung Machine, Cardiopulmonary Bypass (DTQ) (3) Defoamer, cardiopulmonary bypass (DTP) (1) HEAT-EXCHANGER, CARDIOPULMONARY BYPASS (DTR) (1) OXYGENATOR, CARDIOPULMONARY BYPASS (DTZ) (1) RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS (DTN) (1)

Premarket Exempt

No Yes

Clear

QUADROX-i - 04037691780542 Catalog Number : 70105.5117

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTN, DTP

Prescription Use : Yes

Device Count : 1

NA - 04037691780863 Catalog Number : 70105.3921

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691780870 Catalog Number : 70105.3920

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

QUADROX-i - 04037691782072 Catalog Number : 70105.5114

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTZ, DTR

Prescription Use : Yes

Device Count : 1

MAQUET HL-20 System - 04037691786544 Catalog Number : 701020804

Device Description : The DTI 1/4"x1/16" (2 pcs) is a Double Tube Insert RPM, RPM 20-230 functions as The DTI 1/4"x1/16" (2 pcs) is a Double Tube Insert RPM, RPM 20-230 functions as an accessroy for The Heart-Lung Machine HL 20, which is a modular system to drive, control and Monitor extracorporeal circulation. A heart lung machine is used in different surgical and non-surgical specialties. Cardiac surgical procedures requiring cardiopulmonary bypass comprise the vast majority of applications. However, there are some very special procedures that may require a heart-lung machine for extracorporeal bypass support. During these procedures the HL 20 adopts the blood pumping function of the heart while a disposable oxygenator takes over the gas exchange functionalities of the lung.

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTQ

Prescription Use : Yes

Device Count : 1

MAQUET CARDIOHELP - 04037691816432 Catalog Number : 70105.5720

Device Description : MAQUET CARDIOHELP Bubble Sensor BS 3/8x3/32 L1.7

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTQ

Prescription Use : No

Device Count : 1

MAQUET CARDIOHELP - 04037691816449 Catalog Number : 70105.5721

Device Description : MAQUET CARDIOHELP Bubble Sensor BS 3/8x1/16-1/4x3/32 L1.7

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTQ

Prescription Use : No

Device Count : 1

AVALON ELITE - 04037691830674 Catalog Number : 70106.3533

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

AVALON ELITE - 04037691830681 Catalog Number : 70106.3534

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

AVALON ELITE - 04037691830698 Catalog Number : 70106.3529

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

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