BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMICUS Separator Software

    DI: 04086000101912 · Model: 6.0 · Fresenius Kabi AG
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AMICUS Separator Software
    Primary DI
    04086000101912
    Version / Model
    6.0
    Company Name
    Fresenius Kabi AG
    Labeler DUNS
    315654579
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-21
    Public Version
    1
    Public Version Date
    2020-01-29
    Public Version Status
    New
    Public Device Record Key
    6513e3ad-4cbd-4515-b5bf-250f941e1ab3

    Device Description

    Software version for Amicus Separator

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GKT Separator, Automated, Blood Cell, Diagnostic
    LKN Separator, Automated, Blood Cell And Plasma, Therapeutic

    GMDN Terms

    Code Name
    16405 Apheresis system

    Identifiers

    Type ID
    Primary 04086000101912