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 For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.

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 For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.

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 The AMICUS Separator is an automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.

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 The AMICUS Separator is an automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.

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 The AMICUS Separator is an automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.

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 For collection of plasma by membrane filtration. For use with the Plasmacell Xi disposable sets.

Device Class : 2

Duns Number: 315654579

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1