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

Heat-Exchanger, Cardiopulmonary Bypass (DTR) (4) Oxygenator, Cardiopulmonary Bypass (DTZ) (4) CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS (DTQ) (3) Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (KFM) (3) Dialyzer, high permeability with or without sealed dialysate system (KDI) (1)

Premarket Exempt

No Yes

Clear

NA - 04058863039725 Catalog Number : 70106.6547

Device Class :

Duns Number: 316153865

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

MAQUET CARDIOHELP - 04058863074863 Catalog Number : 70107.2780

Device Description : The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system u The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit forcirculatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospitalenvironment (for periods up to six hours), e.g. for intra- and inter-Hospital transport.The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTQ

Prescription Use : Yes

Device Count : 1

HLS Set - 04058863076355 Catalog Number : 701069077

Device Description : HLS Set Advanced 5.0, Small Adult, BIOLINE Coating

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTZ, KFM, DTR

Prescription Use : Yes

Device Count : 1

HLS Set - 04058863078861 Catalog Number : 701069081

Device Description : HIT Set Advanced 7.0, Adult, SOFTLINE Coating

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTZ, DTR, KFM

Prescription Use : Yes

Device Count : 1

HLS Set - 04058863080383 Catalog Number : 701069078

Device Description : HLS Set Advanced 7.0, Adult, BIOLINE Coating

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTZ, DTR, KFM

Prescription Use : Yes

Device Count : 1

Cardiohelp - 04058863084336 Catalog Number : 70107.3079

Device Description : CARDIOHELP mobile holder model HKH 8860. The CARDIOHELP Mobile Holder is for con CARDIOHELP mobile holder model HKH 8860. The CARDIOHELP Mobile Holder is for connecting the CARDIOHELP Base Plate or CARDIOHELP Wall Holder incl. CARDIOHELP protection cover.

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTQ

Prescription Use : Yes

Device Count : 1

MAQUET CARDIOHELP - 04058863112176 Catalog Number : 70107.1881

Device Description : CARDIOHELP Emergency Drive

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTQ

Prescription Use : Yes

Device Count : 1

Quadrox-iD - 04058863154435 Catalog Number : 701070397

Device Description : QUADROX-iD Pediatric with BIOLINE Coating

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTR, DTZ

Prescription Use : Yes

Device Count : 1

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