QURA SRL

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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

Oxygenator, Cardiopulmonary Bypass (DTZ) (4) Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (3) Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (KFM) (3)

Premarket Exempt

No Yes

Clear

Quantum PureFlow Centrifugal Blood Pump CP22 - 08051160300600 Catalog Number :

Device Class : 2

Duns Number: 436188505

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

Quantum PureFlow Centrifugal Blood Pump CP37 - 08051160300617 Catalog Number :

Device Class : 2

Duns Number: 436188505

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors - 08051160300624 Catalog Number :

Device Class : 2

Duns Number: 436188505

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

Quantum Perfusion Blood Oxygenator ECC VT200-E1 - 08051160300679 Catalog Number :

Device Class : 2

Duns Number: 436188505

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

Quantum Perfusion Blood Oxygenator ECC VT200-E2 - 08051160300686 Catalog Number :

Device Class : 2

Duns Number: 436188505

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

Quantum Perfusion Blood Oxygenator ECC VT160-E1 - 08051160300730 Catalog Number :

Device Class : 2

Duns Number: 436188505

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

Quantum Perfusion Blood Oxygenator ECC VT160-E2 - 08051160300747 Catalog Number :

Device Class : 2

Duns Number: 436188505

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

Quantum Perfusion Dual Lumen Cannula 31F - 08051160300792 Catalog Number :

Device Class : 2

Duns Number: 436188505

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Quantum Perfusion Dual Lumen Cannula 27 - 08051160300808 Catalog Number :

Device Class : 2

Duns Number: 436188505

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Quantum Perfusion Dual Lumen Cannula 24F - 08051160300815 Catalog Number :

Device Class : 2

Duns Number: 436188505

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

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