BEUDAMED
    Product Code: KJD FDA class 1 21 CFR 864.2240

    Spinner, Flask

    Hematology

    Spinner Flask is a laboratory vessel equipped with an internal magnetic stirring mechanism used to maintain cells in suspension culture with continuous gentle agitation, enabling homogeneous nutrient distribution and gas exchange for the growth of non-adherent cells or microcarrier-attached cells in large-scale culture. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KJD, regulated under 21 CFR 864.2240, within the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

    View on FDA
    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    KJD
    Device Class
    FDA class 1
    Regulation Number
    864.2240
    Medical Specialty
    Hematology
    Review Panel
    PA
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.