BEUDAMED
    Product Code: PMQ FDA class 2 21 CFR 864.9245

    Peripheral Blood Processing Device For Wound Management

    Hematology

    The Peripheral Blood Processing Device For Wound Management (product code PMQ) is a Class 2 hematology device used to prepare autologous platelet-rich plasma gel from a small sample of peripheral blood for wound management applications, regulated under 864.9245. It requires 510(k) clearance and falls under the hematology medical specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PMQ
    Device Class
    FDA class 2
    Regulation Number
    864.9245
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

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

    Definition

    Preparation of autologous platelet rich plasma gel from a small sample of peripheral blood for wound management.

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.