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510(k) Data Aggregation

    K Number
    K132857
    Device Name
    RESPIRATORY GAS HUMIDIFIER
    Date Cleared
    2014-05-01

    (231 days)

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

    PACIFIC MEDICO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Humidifier Heater Base PMH7000PLUS/PMH7000 is intended to add moisture and to warm the breathing gases for administration to the patient. The Humidifier Heater Base, PMH7000PLUS/PMH7000 is intended for use on adult at hospital and home.
    Device Description
    The Humidifier Heater Base, PMH7000PLUS/PMH7000 is a humidifier incorporating with ventilator and provides respiratory humidification through patient breathing circuit for adult at hospital and home. This heater base features a dual temperature servo control system which regulates the temperature of the gas delivered to the patient and the gas at outlet of humidifying chamber. It continuously monitors temperatures by a dual temperature probe. The heater base warms and humidifies the gas through the humidifier chamber and in addition a heater wire in the patient breathing circuit further controls same gas temperature. The operator is allowed to set the temperature of two locations: temperature of the chamber outlet gas and the gas immediately before delivered to the patient. The Humidifier Heater Base PMH7000PLUS/PMH7000 is equipped with alarms which activate audible and visual indicators to alert the operator of adverse conditions. Alarms are provided for high and low airway temperature, high and low chamber outlet temperature probe disconnect or fault condition, heater wire fault connection, and the light identifies the area of alarm. The Humidifier Heater Base PMH7000PLUS/PMH7000 includes several safety features such as prevention of excessive heating which can be harmful to the patient or can cause damage to the heater base itself. To ensure patient safety, the heater base will shut down under any alarm conditions if it continues for 10 minutes. The Humidifier Heater Base are available in two models, PMH7000PLUS and PMH7000. PMH7000PLUS/PMH7000 has both inspiratory and expiratory heater wires for use in the inspiratory and expiratory limbs of breathing circuit. The use of the expiratory heater wire with PMH7000PLUS/PMH7000 is to control humidity in the expiratory limb and to reduce moisture returned to the ventilator.
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    K Number
    K080149
    Device Name
    HEATER BASE, MODEL PMH7000
    Date Cleared
    2008-12-18

    (331 days)

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

    PACIFIC MEDICO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Humidifier Heater Base PMH7000 is intended to add moisture and to warm the breathing gases for administration to a patient. The Humidifier Heater Base, PMH7000 is intended for use on adult at hospital and home.
    Device Description
    The Humidifier Heater Base, PMH7000 is a humidifier incorporating with ventilator and provides respiratory humidification through patient breathing circuit for adult at hospital and home.
    Ask a Question

    Ask a specific question about this device

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