BEUDAMED
    Product Code: PWW FDA class 2 21 CFR 880.2910

    Fever Monitoring Kit

    General Hospital

    The Fever Monitoring Kit is a general hospital convenience kit containing thermometers and associated accessories used to measure and monitor a patient's body temperature, supporting clinical assessment of fever in hospital or point-of-care settings. Product code PWW is established as a convenience kit under FDA's 1997 Convenience Kits Interim Regulatory Guidance and is under enforcement discretion, not requiring a 510(k) if all guidance criteria are met. Under regulation 21 CFR 880.2910, it is a Class II device subject to general and special controls. It falls under the General Hospital medical specialty and is not flagged as an implant or life-sustaining device.

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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
    PWW
    Device Class
    FDA class 2
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    7

    Device Characteristics

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

    Definition

    This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.