BEUDAMED
    Product Code: MYK FDA not classified

    Kit, Cord Blood Collection

    Unknown

    The Cord Blood Collection Kit is a device used to collect umbilical cord blood at the time of birth for the purpose of banking or direct use in hematopoietic stem cell transplantation. This product code (MYK) is currently not classified by the FDA (classification status "N") and is reviewed by the Hematology panel. The unclassified reason code 6 indicates a specific regulatory pathway situation.

    View on FDA
    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MYK
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    HE
    Submission Type
    7

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Unclassified Reason

    6

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.