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) (6) ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS (KRI) (2) Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (KFM) (2)

Premarket Exempt

No Yes

Clear

CentriMag™ - 07640135140481 Catalog Number : 201-50137

Device Description : Pressure Cable for Argon Medical CDX III Pressure Transducers

Device Class : 1

Duns Number: 486066918

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : No

Device Count : 1

CentriMag Pressure Cable for BD DTX Plus Transducer - 07640135140498 Catalog Number : 104303

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

STANDARD CAPACITY BATTERY MODULE FOR CENTRIMAG BACK-UP CONSOLE - 07640135140528 Catalog Number : 102958

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

THORATEC RECHARGEABLE LI-ION BATTERY - 07640135140535 Catalog Number : 201-50207

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

INTERNAL RECHARGEABLE NIMH BATTERY PACK FOR CENTRIMAG PRIMARY CONSOLE - 07640135140542 Catalog Number : 104172

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

CONSOLE STANDOFF DISTANCE HOLDER - 07640135140559 Catalog Number : 201-52009

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

CentriMag™ - 07640135140566 Catalog Number : 201-52213

Device Description : USB Stick containing Mag Log Converter Software

Device Class : 1

Duns Number: 486066918

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : No

Device Count : 1

CONSOLE TO MONITOR CABLE - 07640135140573 Catalog Number : 201-52147

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

MONITOR ARM - 07640135140580 Catalog Number : 201-52170

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

MONITOR ARM CLAMP - 07640135140597 Catalog Number : 201-52171

Device Class : 2

Duns Number: 486066918

Premarket Exempt : No

Product Code : DWA

Prescription Use : Yes

Device Count : 1

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