BEUDAMED
    Product Code: QIY FDA not classified

    Nasal Spray, Systemic Delivery, Cder Or Cber Led

    Unknown

    The Nasal Spray for Systemic Delivery (CDER or CBER Led) is a drug-device combination product designed to deliver drug substances through the nasal route for systemic therapeutic effect. It is classified as Not Classified (Class N) because the primary mode of action is attributed to the drug component regulated by CDER or CBER rather than the device component. The product code is QIY, reviewed by the General Hospital panel, with no regulation number assigned. The device is not an implant and is not life-sustaining.

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

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    Basic Information

    Product Code
    QIY
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    HO
    Submission Type
    3

    Device Characteristics

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

    Definition

    Nasal spray for systemic delivery of drug substance.

    Unclassified Reason

    4