Terumo Cardiovascular Systems Corporation

Address:28 Howe St,ASHLAND,MA,01721,US

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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) (9) Reservoir, Blood, Cardiopulmonary Bypass (DTN) (8) Defoamer, Cardiopulmonary Bypass (DTP) (7) Heat-Exchanger, Cardiopulmonary Bypass (DTR) (7)

Premarket Exempt

No Yes

Clear

Capiox® SX Hollow Fiber Oxygenator - 00699753450080 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

Capiox® SX Hollow Fiber Oxygenator with Hardshell Reservoir - 00699753450097 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTZ, DTN, DTR, DTP

Prescription Use : Yes

Device Count : 1

Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir - 00699753450103 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTZ, DTN, DTR, DTP

Prescription Use : Yes

Device Count : 1

Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir - 00699753450110 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTZ, DTN, DTR, DTP

Prescription Use : Yes

Device Count : 1

Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir - 00699753450127 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTZ, DTN, DTR, DTP

Prescription Use : Yes

Device Count : 1

Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir - 00699753450134 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTZ, DTN, DTR, DTP

Prescription Use : Yes

Device Count : 1

Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir - 00699753450141 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTZ, DTN, DTR, DTP

Prescription Use : Yes

Device Count : 1

Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir - 00699753450158 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTZ, DTN, DTR, DTP

Prescription Use : Yes

Device Count : 1

Capiox® Hardshell Reservoir - 00699753450165 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

Capiox® Flexible Venous Reservoir - 00699753450196 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTN

Prescription Use : Yes

Device Count : 1

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