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510(k) Data Aggregation

    K Number
    K241465
    Device Name
    Midas Flowmeter; eAVS
    Manufacturer
    Parker Hannifin Corporation
    Date Cleared
    2024-09-19

    (119 days)

    Product Code
    BZR, CBN
    Regulation Number
    868.5330
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Midas Flowmeter is intended for use as a continuous flow conscious sedation system to deliver a mixture of nitrous oxide and oxygen gases to a patient. When used with the electronic automatic vacuum switch (eAVS), the Midas Flowmeter is used to control the scavenging of waste analgesic gas.
    Device Description
    The Midas Flowmeter is used within a healthcare environment during a nitrous oxide (N20)/oxygen (O2) conscious sedation system. The device is a digitally controlled, software driven, continuous flow device that precisely meters nitrous oxide and oxygen medical gases and delivers gas mixtures to a conscious, spontaneously breathing patient. The Midas Flowmeter uses electronic mechanisms to control the flowrate and mixture percentage of gases delivered to a patient. The optional eAVS is an accessory to the Midas Flowmeter. It is used within the nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The eAVS 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 eAVS is specifically designed to work with the Midas Flowmeter and all functionality control of the eAVS has been integrated into the user interface of the Midas Flowmeter.
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    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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    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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    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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    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
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    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
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    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
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    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
    K101286
    Device Name
    SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04
    Manufacturer
    LINDE HEALTHCARE AB
    Date Cleared
    2011-10-20

    (531 days)

    Product Code
    BZR
    Regulation Number
    868.5330
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SEDARA™ Gas Mixer System is indicated for mixing and delivering Nitrous Oxide (N₂O) and Oxygen (0₂), in a ratio of 1:1, at a fixed concentration of 50% / 50% (V/V), to spontaneously breathing patients of at least 15 kg body weight and four years of age, who have been examined by the attending physician prior to SEDARA™ System use and are under the continuous supervision of a healthcare professional in a clinical facility, such as a hospital, a free-standing ambulatory surgical center, or an outpatient clinic.
    Device Description
    USP N₂O and 0₂gases are blended to the 50%/50% concentration (V/V) and delivered upon demand to spontaneously breathing patients through a demand valve internal to the SEDARA™ Gas Mixer. Patient inspiration draws the gas mixture via a breathing circuit with a hand-held strapless face mask. The Oxygen is supplied by the user either from a standard gas cylinder or from an 0₂ wall outlet. The Nitrous Oxide is supplied from a small cylinder equipped with a tamper-resistant valve. The SEDARA™ Gas Mixer can be operated only with the use of a Security Key. The Security Key allows access and activation of the Gas Mixer, secures the N₂O Cylinder in use, and provides safekeeping of incremental N₂O Cylinders in the accompanying Transport Cart storage drawers, to guard against abuse and theft of the gas. The SEDARA™ Gas Mixer is provided with multiple levels of safety to ensure proper dosing. Visual and audible alarms signal the absence of adequate gas flow, the emptying of a gas cylinder, or technical failure of the mixer. The gas exhaled by the patient into the face mask is channeled through the exhalation limb of the breathing circuit to the SEDARA™ Scavenger and removed via the hospital's waste gas disposal system.
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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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    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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    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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