Berlin Heart GmbH

Address:Wiesenweg 10,Berlin,DE

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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

Ventricular (Assisst) Bypass (DSQ) (10)

Premarket Exempt

Clear

EXCOR® VAD - 04260090040409 Catalog Number :

Device Description : Arterial cannula for infans

Device Class : 3

Duns Number: 328654384

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

EXCOR® VAD - 04260090040423 Catalog Number :

Device Description : Atrial cannula for children

Device Class : 3

Duns Number: 328654384

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

EXCOR® VAD - 04260090040430 Catalog Number :

Device Description : Atrial cannula for children

Device Class : 3

Duns Number: 328654384

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

EXCOR® VAD - 04260090040461 Catalog Number :

Device Description : Atrial cannula for small children

Device Class : 3

Duns Number: 328654384

Premarket Exempt : No

Product Code : DSQ

Prescription Use : No

Device Count : 1

EXCOR® VAD - 04260090040492 Catalog Number :

Device Description : Apex cannula for children

Device Class : 3

Duns Number: 328654384

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

EXCOR® VAD - 04260090040508 Catalog Number :

Device Description : Arterial Cannula

Device Class : 3

Duns Number: 328654384

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

EXCOR® VAD - 04260090040515 Catalog Number :

Device Description : Apex cannula for small children

Device Class : 3

Duns Number: 328654384

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

EXCOR® VAD - 04260090040539 Catalog Number :

Device Description : Apex cannula for infants

Device Class : 3

Duns Number: 328654384

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

EXCOR® VAD - 04260090040553 Catalog Number :

Device Description : Accessory set PU valves

Device Class : 3

Duns Number: 328654384

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

EXCOR® VAD - 04260090040560 Catalog Number :

Device Description : Driving tube, red

Device Class : 3

Duns Number: 328654384

Premarket Exempt : No

Product Code : DSQ

Prescription Use : Yes

Device Count : 1

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