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510(k) Data Aggregation

    K Number
    K222351
    Device Name
    inspired™ VHB20 Heated Humidifier
    Date Cleared
    2022-12-21

    (139 days)

    Product Code
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vincent Healthcare Products Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The inspired™ VHB20 Heated Humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases. The inspired TM VHB20 Heated Humidifier is indicated for use by trained personnel only within a hospital/institutional environment. It is compatible with the Fisher and Paykel MR290 Humidification Chamber (Single Use), RT380 Dual Heated Breathing Circuit and RT265 Dual Heated Infant Breathing Circuit.
    Device Description
    The subject device, inspired™ VHB20 Heated Humidifier, is indicated to add humidity and heat to the breathing gasses delivered to patients requiring mechanical ventilation or positive pressure breathing assistance. It consists of an electrically powered heat controlled with a microprocessor to provide software control of the heating element that transfers heat to the water in a chamber. Breathing tubes enable the humidified gas to be transported to the patient which may also be electrically heated (if connected), by means of a heater-wire placed internally to the tubes, to minimize the loss of humidity. A passive electrical adaptor provides electrical energy from the humidifier to the heater-wire in the breathing circuit. Over-current protection is provided by the SMPS inside the inspired™ VHB20 Heated Humidifier, which incorporates an over-current protection that will be triggered (cut-out) if output power of the SMPS reaches 110% of the rating (100W). The SMPS will recover automatically after fault condition is removed, while the humidifier will restart. This safety feature protects the humidifier from short-circuits in the DC part of the circuit, and prevents voltage and current transients on the heater-wire. The inspired™ VHB20 Heated Humidifier provides heated and humidified gas with flow rates of 5 to 60 lpm (invasive) and 5 to 120 lpm (non-invasive). The inspired™ VHB20 Heated Humidifier is a mains powered device that complies with ES60601-1, IEC 60601-1-2, ISO 80601-2-74 and AIM 7351731.
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