BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FRESENIUS KABI WARRENDALE

    Reg #: 3005778453 · FEI: 3005778453 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    61
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    FRESENIUS KABI WARRENDALE
    Registration Number
    3005778453
    FEI Number
    3005778453
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    770 Commonwealth Dr
    City
    WARRENDALE
    State
    PA
    ZIP
    15086
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK150236

    Owner / Operator

    Firm Name
    Fresenius Kabi AG
    Operator Number
    9027285
    Address
    Else-Kroner-Str. 1
    City
    61352 Bad Homburg
    State
    DE-NOTA
    Postal Code
    NONE
    Country
    DE

    Products

    Device Name Product Code
    Separator, Automated, Blood Cell, Diagnostic GKT
    Bone Marrow Collection/Transfusion Kit LWE
    Separator, Automated, Blood Cell And Plasma, Therapeutic LKN
    Supplies, Blood-Bank KSS
    System, Photopheresis, Extracorporeal LNR
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Pump, Infusion FRN
    Set, Administration, Intravascular FPA
    Infusion Safety Management Software PHC
    Blood Establishment Computer Software And Accessories MMH
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Device, Blood Mixing And Blood Weighing KSQ

    Proprietary Names

    ALYX 2RBC LR Kit with Saline Spike ALYX Component Collection System BONE MARROW COLLECTION KIT BONE MARROW COLLECTION STAND Amicus Apheresis Kit – Functionally Closed Single Needle with PAS Spike and Dual Plasma Containers AMICUS Separator AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike Amicus Apheresis Kit – Functionally Closed Double Needle with PAS Spike and Dual Plasma Containers AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike ALYX COMPONENT COLLECTION SYSTEM DXT AMICUS Separator System Alyx Component Collection System PLASMACELL Xi Disposable Set Aurora Xi Plasmapheresis System PLASMACELL-C DISPOSABLE SET AURORA PLASMAPHERESIS SYSTEM AMICUS SEPARATOR SYSTEM ALYX 2RBC-LR Kit ALYX 2RBC DISPOSABLE SET ALYX INSTRUMENT Aurora Plasmapheresis System Software Version 2.1 Slide Clamp Plasma Extractor Phelix Photoactivation Device Aurora Plasmapheresis System Aurora Software Version 1.3 Upgrade Kit LAB EQUIPMENT Hand Sealer Hand Sealer Clip Aurora Xi Plasmapheresis System Software Version 2 ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL) ALYX COMPONENT COLLECTION SYSTEM (ALYX CLASSIC) ALYX PLASMA KIT ALYX 2 RBC-LR Kit ALYX COMPONENT COLLECTION SYSTEM (4R5707, 4R5725) ALYX COMPONENT COLLECTION SYSTEM (6R5725) Ivenix Infusion System (IIS) Centerium Alyx Red Cell Kit LOVO Med Cell Processing System Bone Marrow Collection Kit Bone Marrow Collection Container Bone Marrow Collection Stand DXT Relay Alyx Cart Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters Fenwal Bone Marrow Collection Kit with Accessories BONE MARROW COLLECTION KIT W/ACCESSORIES BONE MARROW COLLECTION KIT WITH ACCESSORIES Bone Marrow Collection Kit and Stand Amicus Separator System AMICUS Exchange Kit - Therapeutics Waste Transfer Set Blood Component Filter Set with Vented Spike and Luer Adapter FRESENIUS KABI DONOR TUBE STRIPPER Adjustable Automatic Donor Scale Support Stand ALYX COMPONENT COLLECTION SYSTEM, 4R5707 ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL), 4R5725 Aurora Xi Plasmapheresis System – Software Version 1.3 Aurora Xi Plasmapheresis System, Software Version 1.2

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Remanufacture Medical Device