BEUDAMED
    Product Code: KSH FDA class 2 21 CFR 864.9575

    Chamber, Environmental For The Storage Of Platelet Concentrate

    Hematology

    This device is an environmental chamber for the storage of platelet concentrate, designed to maintain temperature and agitation conditions required to preserve platelet function and viability during storage prior to transfusion. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSH, regulated under 21 CFR 864.9575 within the Hematology specialty. No special flags apply.

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    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    KSH
    Device Class
    FDA class 2
    Regulation Number
    864.9575
    Medical Specialty
    Hematology
    Review Panel
    HE
    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 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.