BEUDAMED
    Product Code: PHO FDA class 3

    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

    Unknown

    The Normothermic Preservation System for Initially Unacceptable Donor Lungs is a device used to preserve donor lungs under normothermic conditions for transplantation, enabling the assessment and potential use of lungs that would otherwise be deemed unsuitable for transplant. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA), reviewed by the Gastroenterology and Urology (GU) panel with no assigned regulation number or medical specialty. The product code is PHO, and it carries a life-sustaining flag given its role in organ transplantation. This device is not implanted in the patient.

    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
    PHO
    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

    Preservation of donor lungs for transplantation.

    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.