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510(k) Data Aggregation

    K Number
    K131990
    Device Name
    OXYGEN GENERATOR LIQUEFIER - (OGL)
    Manufacturer
    ESSEX CRYOGENICS OF MISSOURI, INC.
    Date Cleared
    2014-02-21

    (238 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESSEX CRYOGENICS OF MISSOURI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OGL is intended to be used by emergency response personnel in military and commercial applications to produce emergency source of 93% USP liquid oxygen (LOX) which will be transferred into portable LOX systems. The portable LOX systems are used as an emergency source of supplemental oxygen for patient(s) while being transported for a crisis situation to a health care facility. This medical device is for supplemental oxygen and is not intended to sustain or support life.
    Device Description
    The OGL is a device that generates 93% USP oxygen gaseous, liquefy it into LOX and store up to 40 liters of LOX. It OGL is a single module that weighs approximately 730 LBS empty or 830 full of LOX. The system is 52" long, 33" wide and 48" tall if the wheels are deployed). The system has to forklift pockets to allow the system to be moved by a forklift. The system also has retractable wheels that allows for one or two persons to easily move the device on a flat smooth surface. The OGL requires only 200-240 VAC, 50/60 Hz 30 amp single phase power supply for operation. The system is very simple to operate. The control panel has a mode switch that allows the user to make liquid oxygen (LOX), generate gaseous oxygen for the oxygen gas port or transfer the liquid oxygen to a separate device. The control panel also has fault indicators if there is a problem with the system, emergency stop button, hour meter, Dewar pressure gauge and LOX quantity gauge.
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    K Number
    K071581
    Device Name
    BACKPACK MEDICAL OXYGEN SYSTEM
    Manufacturer
    ESSEX CRYOGENICS OF MISSOURI, INC.
    Date Cleared
    2007-07-11

    (33 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESSEX CRYOGENICS OF MISSOURI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BMOS is intended to be used by emergency response personnel in military and commercial fields to provide an emergency source of supplemental oxygen for one patient while being transported from a crisis situation to a health care facility. The BMOS is not intended to be a life sustaining or a life-supporting device.
    Device Description
    The BMOS is a portable thermally insulated container that provides, when filled with liquid oxygen (LOX), an uninterrupted supply of supplemental oxygen gas to be inhaled by the patient. BMOS is operated by trained emergency response to administer patients with variable amounts of gaseous oxygen in doses measured in liters per minute (LPM).
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    K Number
    K033000
    Device Name
    NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
    Manufacturer
    ESSEX CRYOGENICS OF MISSOURI, INC.
    Date Cleared
    2004-03-22

    (179 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESSEX CRYOGENICS OF MISSOURI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NPILOX is intended to convert liguid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery at 50 psig nominal for military use settings only.
    Device Description
    The NPTLOX is a portable, thermally insulated container designed to store liquid oxygen (99.9%) and convert the liquid oxygen to gaseous form, which provides therapeutic oxygen to patients. This equipment meets the Aero-medical mission requirements for gaseous oxygen to be delivered to patients in the three methods listed below. - 1240 DISS Flow control valves and humidifier bottles - Laerdal Silicone Adult Resuscitators with 2500 ml reservoirs - Impact 754 Eagle Ventilators The NPTLOX has six outlet ports that are capable of delivering oxygen to a maximum of six ambulatory or litter patients according to one or more of these approved methods. The system will be filled by current liquid oxygen storage/filling systems used in the United States Military. The design of the NPTLOX is a modification to the existing predicate device, the Portable Therapeutic Liquid Oxygen (PTLOX) 510(k) K880183. The major modifications are an improvement in maximum oxygen delivery rate, increased number of patient outlets and increased oxygen capacity. The NPTLOX provides gaseous oxygen to patients through 6 outlet ports at an outlet pressure of 50 ± 5 psig. The 6 outlet ports have a maximum combined system outlet flow of 66 LPM. This continuous flow rate is based on a design standard of 11 LPM per outlet fitting. The system is capable of flowing at least 60 LPM to meet the ventilator peak flow requirement. The NPLTOX has an accessory kit that includes three of each of the following: medical hoses, 0-15 LPM flow control valves, and humidifier bottles. The LOX capacity of the system is 20 liters. Oxygen delivery pressure is displayed via a pressure gauge. The LOX quantity can be periodically displayed via a LOX quantity indicator that is powered by two 9 volt batteries. There is no other electronics or software in the NPTLOX.
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    K Number
    K022684
    Device Name
    PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)
    Manufacturer
    ESSEX CRYOGENICS OF MISSOURI, INC.
    Date Cleared
    2002-09-11

    (30 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESSEX CRYOGENICS OF MISSOURI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provides supplemental therapeutic oxygen to a patient in a military field hospital setting.
    Device Description
    The Portable Therapeutic Oxygen Concentration System (PTOCS) has been designed to accommodate Military Personnel with a source of supplemental oxygen in a setting where liguid oxygen may be unavailable. Aeromedical Evacuation and ground based medical missions require medical support systems capable of providing therapeutic oxygen. The gaseous oxygen generator will also be required to provide oxygen at the prescribed flow rates and pressures required to operate the oxygen driven equipment included in the AFMS deployable medical assemblages. Requirements are based on the deployable oxygen system, operational requirements document that has been issued by the United States Air Force. This system is based on the Pressure Swing Adsorption principle and uses a molecular sieve to separate gases from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through one of three ports (1/2 to 15 lpm settings) with a maximum litre per minute flow of 45 total at 50 psig. The oxygen concentration purity level is at 93% minimum, with an oxygen purity level average of 95%. Included with the generator is a secured accessory kit consisting of 20 feet of medical grade oxygen hose and flow regulators for each outlet.
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