BEUDAMED
    Product Code: PIZ FDA class 3

    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

    Unknown

    The Combination Compression/Decompression Manual Chest Pump with Impedance Respiratory Valve is a CPR adjunct device intended to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest by combining active chest compression and decompression with an impedance threshold valve. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA), reviewed by the Cardiovascular (CV) panel. The product code is PIZ, and it carries a life-sustaining flag given its critical role during cardiac resuscitation. No regulation number or medical specialty has been formally assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PIZ
    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

    Intended for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest.

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.