BEUDAMED
    Product Code: QLD FDA not classified

    Protective Barrier Enclosure

    Unknown

    The Protective Barrier Enclosure is a not-classified device designed as a transparent enclosure covering a patient's head and upper body with one or more ports through which healthcare providers can perform medical procedures, providing an extra layer of barrier protection in addition to standard PPE during the declared COVID-19 public health emergency. The product code is QLD, reviewed by the General Hospital panel, with no regulation number assigned. The device is not an implant and is not flagged as life-sustaining.

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

    Basic Information

    Product Code
    QLD
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    HO
    Submission Type
    8

    Device Characteristics

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

    Definition

    A transparent device designed to cover a patient's head and upper body and incorporates one or more ports through which the HCP's hands are passed to perform medical procedures. Device provides extra layer of barrier protection, in addition to PPE, during the declared public health emergency.

    Unclassified Reason

    11