BEUDAMED
    Product Code: KSW FDA class 2 21 CFR 864.9145

    System, Processing For Frozen Blood

    Hematology

    This device is a processing system for frozen blood, used to thaw, wash, and reconstitute cryopreserved red blood cells to remove the cryoprotective agent (typically glycerol) prior to transfusion, restoring the cells to a transfusable state. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSW, regulated under 21 CFR 864.9145 within the Hematology specialty. No special flags apply.

    View on FDA
    510(k)s
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    KSW
    Device Class
    FDA class 2
    Regulation Number
    864.9145
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    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
    K760914 DOUBLE ELUTRA-PACK UNIT

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.