BEUDAMED
    Product Code: OJL FDA class 1 21 CFR 890.5050

    Insulin Vial Protector/Holder

    Physical Medicine

    The Insulin Vial Protector/Holder is a device intended to protect one or more insulin vials from physical damage, helping patients with diabetes safely store and handle their insulin. Classified as FDA Class 1 under regulation 21 CFR 890.5050 within the Physical Medicine medical specialty, it is subject to general controls only and qualifies for a 510(k) exemption. The product code is OJL. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    OJL
    Device Class
    FDA class 1
    Regulation Number
    890.5050
    Medical Specialty
    Physical Medicine
    Review Panel
    HO
    Submission Type
    4

    Device Characteristics

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

    Definition

    The device is intended to protect an insulin vial or vials

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.