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510(k) Data Aggregation

    K Number
    K110930
    Device Name
    ACTIVE WASTE GAS SCAVENGER
    Manufacturer
    Date Cleared
    2011-06-23

    (80 days)

    Product Code
    Regulation Number
    868.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    G. DUNDAS CO.,INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Waste Gas Scavenger is designed for use with vacuum (suction) waste gas disposal systems with anesthesia machines and heart/lung bypass machines.
    Device Description
    Active Waste Gas Scavenger
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    K Number
    K080039
    Device Name
    PASSIVE WASTE GAS SCAVENGER, MODEL 14600
    Manufacturer
    Date Cleared
    2008-04-14

    (98 days)

    Product Code
    Regulation Number
    868.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    G. DUNDAS CO.,INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Passive Waste Gas Scavenger is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children. The Passive Waste Gas Scavenger is designed for use with non-recirculating waste gas disposal systems and is intended for prescription use only.
    Device Description
    The Passive Waste Gas Scavenger is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children. The Passive Waste Gas Scavenger is designed for use with non-recirculating waste gas disposal systems and is intended for prescription use only. This scavenging approach relies on the pressure of the waste gas to transfer the gas from the scavenger to the exhaust system. The scavenger body incorporates one 30mm/27mm/19mm horizontal hose terminal to connect the scavenger to the anesthesia machine. The vertically oriented 30mm/19mm hose terminal is intended to connect the scavenger to the exhaust system. The G. Dundas Passive Scavenger incorporates the same safety systems as predicate devices, providing relief of excess positive pressure and excess negative pressure to the patient through the use of pressure relief valves, in compliance with ASTM 1343-02 -Anesthetic Equipment -- Scavenging Systems for Anesthetic Gases. Although there is no standard for passive waste gas scavenging systems, the G. Dundas Passive Scavenger is designed to fail safe under active waste disposal conditions. The G. Dundas Passive Scavenger and the predicate devices were tested and found to have similar performance. Testing procedures and data can be found in Section 7 of this application.
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    K Number
    K963601
    Device Name
    MODEL 1920 WASTE GAS SCAVENGER
    Manufacturer
    Date Cleared
    1997-04-28

    (231 days)

    Product Code
    Regulation Number
    868.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    G. DUNDAS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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