BEUDAMED
    Product Code: PWQ FDA class 2 21 CFR 880.5440

    Buret Administration Intravenous Kit

    General Hospital

    The Buret Administration Intravenous Kit is a general hospital convenience kit containing a buret (burette) chamber and associated IV administration set components, used for precise measurement and controlled delivery of small volumes of intravenous fluids or medications, particularly in pediatric or critical care settings. Product code PWQ 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 880.5440, 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
    PWQ
    Device Class
    FDA class 2
    Regulation Number
    880.5440
    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.