BEUDAMED
    Product Code: KSD FDA class 1 21 CFR 864.9750

    Device, Heat-Sealing

    Hematology

    This device is a heat-sealing device used in blood banking to hermetically seal plastic tubing on blood collection bags and transfer sets, maintaining a sterile, closed system and preventing leakage or contamination of blood products. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is KSD, regulated under 21 CFR 864.9750 within the Hematology specialty. No special flags apply.

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    510(k)s
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KSD
    Device Class
    FDA class 1
    Regulation Number
    864.9750
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K820301 PLASMA POOLER HEAT SEALER

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.