BEUDAMED
    Product Code: QBA FDA class 3

    Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

    Unknown

    The Normothermic Machine Perfusion System for the Preservation of Standard Criteria Donor Lungs Prior to Transplantation is a device intended to preserve donor lungs under normothermic conditions prior to transplantation, extending organ viability and potentially improving transplant outcomes. It is classified as a Class 3 device requiring Premarket Approval (PMA) given its critical role in organ transplantation; no regulation number has been assigned. The product code is QBA, reviewed by the Gastroenterology/Urology (GU) panel. It is not flagged as an implant or life-sustaining in the record.

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    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QBA
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    GU
    Submission Type
    2

    Device Characteristics

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

    Definition

    To preserve donor lungs prior to transplantation

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.