Terumo Cardiovascular Systems Corporation

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

Accessory Equipment, Cardiopulmonary Bypass (KRI) (5) Heat-Exchanger, Cardiopulmonary Bypass (DTR) (5)

Premarket Exempt

No Yes

Clear

Sarns™ Cardioplegia Set - 00699753000278 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

Sarns™ Cardioplegia Set - 00699753001213 Catalog Number :

Device Class : 1

Duns Number: 177655466

Premarket Exempt : No

Product Code : KRI

Prescription Use : Yes

Device Count : 1

Sarns™ Cardioplegia Set - 00699753001367 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

Sarns™ Cardioplegia Set - 00699753001381 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

Sarns™ Cardioplegia Set - 00699753001534 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

Sarns™ Cardioplegia Set - 00699753001541 Catalog Number :

Device Class : 2

Duns Number: 177655466

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

Sarns™ Infusion Line - 00699753001947 Catalog Number :

Device Class : 1

Duns Number: 177655466

Premarket Exempt : No

Product Code : KRI

Prescription Use : Yes

Device Count : 1

Sarns™ Cardioplegia Delivery Line - 00699753001954 Catalog Number :

Device Class : 1

Duns Number: 177655466

Premarket Exempt : No

Product Code : KRI

Prescription Use : Yes

Device Count : 1

Sarns™ Infusion Line - 00699753001961 Catalog Number :

Device Class : 1

Duns Number: 177655466

Premarket Exempt : No

Product Code : KRI

Prescription Use : Yes

Device Count : 1

Sarns™ Cardioplegia Set - 00699753002005 Catalog Number :

Device Class : 1

Duns Number: 177655466

Premarket Exempt : No

Product Code : KRI

Prescription Use : Yes

Device Count : 1

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