BEUDAMED
    Product Code: OZD FDA class 3

    Temporary Non-Roller Type Left Heart Support Blood Pump

    Unknown

    The Temporary Non-Roller Type Left Heart Support Blood Pump is a cardiovascular device designed to provide temporary full or partial left heart support, used in patients with acute heart failure or during high-risk cardiac procedures. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA) due to its life-sustaining function. The product code is OZD, with a life-sustaining/support flag, reviewed under the cardiovascular panel, with no regulation number assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    OZD
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

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

    Definition

    A blood pump that provides temporary full or partial left heart support

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.