Fresenius Kabi AG

Address:Fresenius Kabi AB,Uppsala,SE

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Device Description : Aurora Plasmapheresis System Software Version 2.1

Device Class :

Duns Number: 315654579

Premarket Exempt : No

Product Code : GKT

Prescription Use : No

Device Count : 1

Device Description : For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma

Device Class :

Duns Number: 315654579

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Device Description : For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Pla

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Device Description : Software version for AMICUS Separator life extension device

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : GKT, LKN

Prescription Use : No

Device Count : 1

- Catalog Number : 6R4590

Device Description : The AMICUS Separator is an automated blood cell separator indicated for the coll

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : GKT, LKN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6R4590TH-T

Device Description : The AMICUS Separator is an automated blood cell separator indicated for the coll

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : GKT, LKN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6R4590TH-M

Device Description : The AMICUS Separator is an automated blood cell separator indicated for the coll

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : GKT, LKN

Prescription Use : Yes

Device Count : 1

Device Description : AURORA Software Version 2.1C for collection of plasma by membrane filtration.

Device Class :

Duns Number: 315654579

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Device Description : Adjustable Automatic Donor Scale Support Stand

Device Class : 1

Duns Number: 315654579

Premarket Exempt : Yes

Product Code : KSQ

Prescription Use : Yes

Device Count : 1

Device Description : For collection of plasma by membrane filtration. For use with the Plasmacell Xi

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1