BEUDAMED
    Product Code: PYV FDA class 2 21 CFR 862.1345

    Hospital Continuous Glucose Monitoring System

    Clinical Chemistry

    The Hospital Continuous Glucose Monitoring System is an in vitro diagnostic device intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting, used to monitor glycemic status in hospitalized patients. It is classified as a Class 2 device under regulation 862.1345, requiring 510(k) premarket notification before marketing. The product code is PYV, and it falls within the Clinical Chemistry (CH) medical specialty. It 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
    PYV
    Device Class
    FDA class 2
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

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

    Definition

    Intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting.