BEUDAMED
    Product Code: QLE FDA not classified

    Protective Barrier Enclosure With Negative Pressure

    Unknown

    The Protective Barrier Enclosure With Negative Pressure is a not-classified barrier device with negative pressure capability that partially or fully covers a patient to prevent healthcare provider exposure to pathogenic biological airborne particulates, incorporating ports for medical care and procedures, intended for use during the declared COVID-19 public health emergency. The product code is QLE, 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
    QLE
    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 barrier device with negative pressure which partially or fully covers a patient to prevent HCP exposure to pathogenic biological airborne particulates. These barrier devices include ports for medical care and/or procedures. Device intended to be used during declared public health emergency.

    Unclassified Reason

    11