BEUDAMED
    Product Code: QPK FDA not classified

    Eua Faceshields

    Unknown

    The EUA Faceshields are authorized face shield devices intended for use as personal protective equipment (PPE) during a declared public health emergency, providing a physical barrier to protect the face from splashes, sprays, and respiratory droplets. They were authorized under an FDA EUA and are not formally classified by device class. Product code QPK, reviewed by the General Hospital panel. The device is not an implant and is not life-sustaining.

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

    Basic Information

    Product Code
    QPK
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    HO
    Submission Type
    7

    Device Characteristics

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

    Definition

    Authorized faceshields intended for use during the declared public health emergency.

    Unclassified Reason

    11