BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HemaPrep

    DI: 07350040976753 · Model: XU-10012-01 · Cellavision AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    HemaPrep
    Primary DI
    07350040976753
    Version / Model
    XU-10012-01
    Company Name
    Cellavision AB
    Labeler DUNS
    508663101
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-06
    Public Version
    1
    Public Version Date
    2023-01-16
    Public Version Status
    New
    Public Device Record Key
    b5ed9edd-7af5-444e-ae66-9985342b750a

    Device Description

    Semi-Automated Blood Smearing Device

    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GKJ Spinner, Slide, Automated

    GMDN Terms

    Code Name
    62550 Blood smearing manual instrument IVD

    Identifiers

    Type ID
    Primary 07350040976753