Thoratec Switzerland GmbH

Address:TECHNOPARKSTRASSE 1,ZURICH,CH

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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

Control, Pump Speed, Cardiopulmonary Bypass (DWA) (3) ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS (KRI) (2)

Premarket Exempt

No Yes

Clear

SQUARE OXYGENATOR BRACKET - 07640135140818 Catalog Number : 201-50144

Device Class : 1

Duns Number: 486066918

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : No

Device Count : 1

CMAG TRANSPORTER, SPARE PART KIT - 07640135140825 Catalog Number : 201-50147

Device Class : 1

Duns Number: 486066918

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : No

Device Count : 1

CENTRIMAG® Back-Up Console with Batteries - 07640135140863 Catalog Number : 102966

Device Description : Back-Up Console with Batteries

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

CENTRIMAG® BACK-UP CONSOLE WITH BATTERIES - 07640135140870 Catalog Number : 201-90200

Device Description : BACK-UP CONSOLE WITH BATTERIES

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

CENTRIMAG® BACK-UP CONSOLE WITH BATTERIES - 07640135140887 Catalog Number : 201-90220

Device Description : BACK-UP CONSOLE WITH BATTERIES

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

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