BEUDAMED
    Product Code: QJY FDA class 2 21 CFR 880.5725

    Infusion Pump, Drug Specific, Pharmacy-Filled

    General Hospital

    The Infusion Pump, Drug Specific, Pharmacy-Filled is a Class 2 general hospital prescription device intended for the delivery of a specific drug in accordance with FDA-approved labeling, and may be filled at a location other than the point of care. It requires 510(k) clearance and is regulated under 21 CFR 880.5725 within the General Hospital medical specialty. The product code is QJY. The device is not an implant and is not flagged as life-sustaining.

    View on FDA
    510(k)s
    4
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    3
    Years Active
    5

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    Basic Information

    Product Code
    QJY
    Device Class
    FDA class 2
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

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

    Definition

    A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K243354 Remunity System
    K240256 Remunity System
    K202690 Remunity Pump for Remodulin (treprostinil) Injection
    K191313 Unity Subcutaneous Infusion System for Remodulin

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.