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510(k) Data Aggregation

    K Number
    K223452
    Device Name
    Nitronox Scavenger Plus
    Manufacturer
    Parker Hannifin Corporation
    Date Cleared
    2023-03-05

    (110 days)

    Product Code
    CBN
    Regulation Number
    868.5430
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    Product Code :

    CBN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitronox® Scavenger Plus is intended to control the vacuum flowrate for scavenging of waste analgesic gas.
    Device Description
    The Nitronox® Scavenger Plus (Scavenger Plus) is used within a nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The device is used during a dental or medical procedure in a healthcare facility environment. The device is not intended to be used for general anesthesia. The Scavenger Plus is operated by a licensed healthcare professional during conscious sedation of a patient. The Scavenger Plus connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The rate at which the gas is removed (i.e., scavenged) is specified by the Scavenger Plus, which uses a control knob and reservoir bag to limit the amount of vacuum applied to the exhalation line of the breathing circuit.
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    K Number
    K193646
    Device Name
    Dynamic Gas Scavenging System 2 (DGSS - 2)
    Manufacturer
    Anesthetic Gas Reclamation, Inc.
    Date Cleared
    2020-12-04

    (340 days)

    Product Code
    CBN
    Regulation Number
    868.5430
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    Product Code :

    CBN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dynamic Gas Scavenging System is intended to be used for the scavenging of waste anesthesia machines during the provision of general anesthesia to adults and children.
    Device Description
    The Dynamic Gas Scavenging System 2 (DGSS-2) is a waste anesthetic scavenging interface placed between the individual anesthetic workstation and the waste gas evacuation vacuum system in a surgical care facility. Through a sensor and solenoid combination, it allows waste gas exhaust flow to the waste gas vacuum line only in the presence of waste anesthetic gas, and interrupts all exhaust flow when no waste gas is present. The system effectively prevents both positive and negative pressure on the patient breathing circuit, and it is usable over a wide range of anesthetic gas flows. It is designed for use in conjunction with low-flow (<50 liters/min) waste gas disposal (WAGD) systems.
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    K Number
    K160950
    Device Name
    MINISCAV
    Manufacturer
    Sedation Systems LLC
    Date Cleared
    2017-05-05

    (395 days)

    Product Code
    CBN, BTA
    Regulation Number
    868.5430
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    Product Code :

    CBN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases. This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.
    Device Description
    The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a standard flexible vacuum hose to nitrous oxide / oxygen delivery equipment. The vacuum hose is connected to the "vacuum / suction" nipple on exemplary equipment. The MINISCAVIM is a diaphragm hermetically sealed pump with a fixed vacuum flow rate. The inlet line is connected to a flowmeter exhaust port of the nitrous oxide / oxygen delivery equipment which has an exhaust port for scavenging gases.
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    K Number
    K142138
    Device Name
    ISO-GARD MASK
    Manufacturer
    Teleflex Medical, Inc.
    Date Cleared
    2014-10-30

    (86 days)

    Product Code
    CBN
    Regulation Number
    868.5430
    Why did this record match?
    Product Code :

    CBN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ISO-Gard® Mask is intended to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen. The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
    Device Description
    The ISO-Gard Mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAG) exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit (PACU). Vacuum/suction for scavenging of WAG is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers. The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port.
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    K Number
    K132729
    Device Name
    ISO-GARD MASK
    Manufacturer
    Teleflex Medical, Inc.
    Date Cleared
    2014-01-09

    (128 days)

    Product Code
    CBN
    Regulation Number
    868.5430
    Why did this record match?
    Product Code :

    CBN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ISO-Gard® Mask is intended to be used to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen. The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
    Device Description
    The ISO-Gard Mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAGS) exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit (PACU). Vacuum/suction for scavenging of WAGS is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers. The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port.
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    K Number
    K123176
    Device Name
    ISO-GARD CLEARAIR MASK
    Manufacturer
    Teleflex Medical, Inc.
    Date Cleared
    2013-02-14

    (127 days)

    Product Code
    CBN
    Regulation Number
    868.5430
    Why did this record match?
    Product Code :

    CBN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ISO-GARD® ClearAir™ Mask is intended to be used to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen. The ISO-GARD® ClearAir™ Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
    Device Description
    The ISO-GARD® ClearAir™ mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases ("WAGS") exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit ("PACU"). Vacuum/suction for scavenging of WAGS is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers. The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port. The ISO-GARD® ClearAir™ mask is offered in several configurations, the differences being some of the components.
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    K Number
    K110930
    Device Name
    ACTIVE WASTE GAS SCAVENGER
    Manufacturer
    G. DUNDAS CO.,INC.
    Date Cleared
    2011-06-23

    (80 days)

    Product Code
    CBN
    Regulation Number
    868.5430
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    Product Code :

    CBN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    K092031
    Device Name
    VAPOR-CLEAR, MODEL 100
    Manufacturer
    AXON MEDICAL, INC.
    Date Cleared
    2010-04-16

    (284 days)

    Product Code
    CBN
    Regulation Number
    868.5430
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    Product Code :

    CBN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To remove unwanted anesthetic gases from the patient breathing circuit
    Device Description
    This device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthetic vapors emanating from within an anesthesia gas machine from reaching a patient.
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    K Number
    K080039
    Device Name
    PASSIVE WASTE GAS SCAVENGER, MODEL 14600
    Manufacturer
    G. DUNDAS CO.,INC.
    Date Cleared
    2008-04-14

    (98 days)

    Product Code
    CBN
    Regulation Number
    868.5430
    Why did this record match?
    Product Code :

    CBN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    K072255
    Device Name
    MINRAD INC. NASAL SCAVENGING CIRCUIT
    Manufacturer
    MINRAD, INC.
    Date Cleared
    2007-10-18

    (66 days)

    Product Code
    CBN
    Regulation Number
    868.5430
    Why did this record match?
    Product Code :

    CBN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The single-use Nasal Scavenging Circuit is intended to be used in conjunction with a conscious sedation system for the delivery of medical gases to the patient, and for the removal of expired, excess and unused gases from the treatment location.
    Device Description
    The single-use Nasal Scavenging Circuit is designed for the removal of patient expired and excess gases during conscious sedation procedures.
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