BEUDAMED
    Product Code: QZV FDA class 3

    Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury

    Unknown

    The pediatric extracorporeal synthetic semipermeable membrane cartridge for acute kidney injury (product code QZV) is a Class 3 device reviewed by the Hematology panel, intended for the treatment of acute kidney injury in pediatric patients in conjunction with continuous kidney replacement therapy (CKRT). As a Class 3 device, it requires PMA due to the high-risk nature of extracorporeal renal support in pediatric patients. No regulation number has been assigned. It is designated as life-sustaining, reflecting its critical role in renal support, and is not an implant.

    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QZV
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    HE
    Submission Type
    6

    Device Characteristics

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

    Definition

    For the treatment of acute kidney injury in pediatric patients, in conjunction with continuous kidney replacement treatment (CKRT).

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.