BEUDAMED
    Product Code: FJM FDA class 2 21 CFR 876.5540

    Guard, Shunt

    Gastroenterology, Urology

    The Shunt Guard is a protective covering or sleeve placed over an arteriovenous shunt or fistula to protect it from trauma, infection, or accidental dislodgement in patients undergoing hemodialysis. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FJM, regulated under 21 CFR 876.5540, within the Gastroenterology, Urology medical specialty.

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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
    FJM
    Device Class
    FDA class 2
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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