Maquet Cardiopulmonary AG

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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) (4) Defoamer, cardiopulmonary bypass (DTP) (3) FILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS (JOD) (3) RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS (DTN) (3) Dilator, Vessel, For Percutaneous Catheterization (DRE) (2) HEAT-EXCHANGER, CARDIOPULMONARY BYPASS (DTR) (1) OXYGENATOR, CARDIOPULMONARY BYPASS (DTZ) (1)

Premarket Exempt

No Yes

Clear

AVALON ELITE - 04037691830704 Catalog Number : 70106.3535

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

AVALON ELITE - 04037691830711 Catalog Number : 70106.3538

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

AVALON ELITE - 04037691830933 Catalog Number : 70106.3537

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

AVALON ELITE - 04037691831022 Catalog Number : 70106.3536

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

AVALON ELITE - 04037691831039 Catalog Number : 70106.3540

Device Description : Vascular Access Kit

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

AVALON ELITE - 04037691831046 Catalog Number : 70106.3539

Device Description : Vascular Access Kit

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

NA - 04037691833545 Catalog Number : 70106.2605

Device Description : Venous Hardshell Cardiotomy Reservoir, Adult: VHK 71000#Venöses Reservoir VHK 71 Venous Hardshell Cardiotomy Reservoir, Adult: VHK 71000#Venöses Reservoir VHK 71000, vacuum-tight.

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTN, JOD, DTP

Prescription Use : Yes

Device Count : 1

VHK Venous Reservoir - 04037691838663 Catalog Number : 70106.3858

Device Description : Venous Hardshell Cardiotomy Reservoir, Adult, Vacuum-tight, with SOFTLINE Coatin Venous Hardshell Cardiotomy Reservoir, Adult, Vacuum-tight, with SOFTLINE Coating, without screw connector, Sterile. The Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood. The vacuum-tight version of the VHK reservoir (VHK 71000) can also be employed postoperatively as drainage and auto-transfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTP, JOD, DTN

Prescription Use : Yes

Device Count : 1

QUADROX-i - 04037691843346 Catalog Number : 70105.5281

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTR, DTZ

Prescription Use : Yes

Device Count : 1

VHK reservoir Ad - 04037691854984 Catalog Number : 70106.2604

Device Description : Venous Hardshell Cardiotomy Reservoir, Adult, non-coated, with cardiotomy filter Venous Hardshell Cardiotomy Reservoir, Adult, non-coated, with cardiotomy filter, without screw connector, Sterile. The Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood. The vacuum-tight version of the VHK reservoir can also be employed postoperatively as drainage and auto-transfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTP, JOD, DTN

Prescription Use : Yes

Device Count : 1

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