Address:Fresenius Kabi AB,Uppsala,SE
Device Description : Therapeutic Plasma Treatment (e.g. LDL-apheresis)
Device Class :
Duns Number: 315654579
Premarket Exempt : No
Prescription Use : Yes
Device Description : Blood Component Recipient Set with Standard Blood Filter with Luer Adapter. Ster Blood Component Recipient Set with Standard Blood Filter with Luer Adapter. Sterile Fluid Path
Device Class : 2
Duns Number: 315654579
Premarket Exempt : No
Prescription Use : Yes
Device Description : Transfer Pack Container 600 mL with 8 couplers. Sterile Fluid Path
Device Class : 2
Duns Number: 315654579
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Y-Type Blood Component Recipient Set with Standard Blood Filter and Luer Adapter Y-Type Blood Component Recipient Set with Standard Blood Filter and Luer Adapter. Sterile Fluid Path
Device Class : 2
Duns Number: 315654579
Premarket Exempt : No
Prescription Use : Yes
Device Description : Red Cell Freezing Pack 2000 mL
Device Class : 2
Duns Number: 315654579
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell RS-2 LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell RS-2000 Filter for Red Blood Cells in Additive Solution
Device Class : 2
Duns Number: 315654579
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ATV-F140C Vacuum Lines Combi-pack consists of:1: vacuum tube with integrated The ATV-F140C Vacuum Lines Combi-pack consists of:1: vacuum tube with integrated filter2: vacuum tube including clamp and yellow cap3: "smoke connector"
Device Class :
Duns Number: 315654579
Premarket Exempt : No
Prescription Use : Yes
Device Description : For Administration of Blood and Blood Components During a Therapeutic Plasma Exc For Administration of Blood and Blood Components During a Therapeutic Plasma Exchange (TPE) or Red Blood Cell Exchange (RBCX) Therapeutic Apheresis Procedure. For use with the AMICUS separator. Sterile Fluid Path.
Device Class :
Duns Number: 315654579
Premarket Exempt : No
Prescription Use : Yes
Device Description : For Red Blood Cell Exchange (RBCX) Procedures. For use with the AMICUS Separator For Red Blood Cell Exchange (RBCX) Procedures. For use with the AMICUS Separator. Sterile Fluid Path.
Device Class :
Duns Number: 315654579
Premarket Exempt : No
Prescription Use : Yes
Device Description : Vigilant Drug'Lib AGILIA US is a dose error reduction software. It is installed Vigilant Drug'Lib AGILIA US is a dose error reduction software. It is installed on a PC Platform for communication with the Volumat MC Agilia infusion pump via a USB cable
Device Class : 2
Duns Number: 315654579
Premarket Exempt : No
Prescription Use : Yes