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510(k) Data Aggregation

    K Number
    K130068
    Device Name
    DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
    Manufacturer
    ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M
    Date Cleared
    2013-07-19

    (189 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Product Code :

    BYJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and/or for delivery to rescue personnel to supplement environmental oxygen at high altitudes while being carried by a rescue personnel at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).
    Device Description
    The DMOS, when filled with liquid oxygen, will be used to provide medical oxygen treatment to injured personnel or provide supplemental oxygen to operator during dismounted operations above 10,000 feet MSL. The DMOS provides for storing of 1.4 liters of liquid oxygen and converting this liquid into its gaseous state. The gaseous oxygen is capable of being delivered in controlled amounts to provide medical treatment to injured patients and uncontrolled amounts to drive respiratory medical devices or supplemental oxygen in high altitude. The DMOS is capable of being filled with liquid oxygen from the Oxygen Generator System (OGS) and with current liquid oxygen storage/ filling stations. The DMOS contains a thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient. The DMOS supports medical devices provided by the user including masks, cannulas, and Bag Valve Mask (BVM) being attached to the flow control patient outlets. The DMOS is portable and can be carried onboard, tied down, transported and operationally perform on various aircraft and ground vehicles. The DMOS converts liquid oxygen from its insulated container through its heat exchanger into gaseous oxygen and finally the gaseous oxygen is available for distribution from an outlet port on the user interface.
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    K Number
    K113767
    Device Name
    MOUNTED MEDICAL OXYGEN SYSTEM
    Manufacturer
    ESSEX INDUSTRIES, INC.
    Date Cleared
    2012-06-29

    (191 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Product Code :

    BYJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and for delivery to rescue personnel to supplement environmental oxygen at high altitudes while mounted in rescue vehicles, e.g. HH-60 and HC-130 Guardian Angel (GA) rescue vehicles, at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).
    Device Description
    The MMOS, when filled with liquid oxygen, is used to provide medical treatment to injured isolated personnel and to supplement environmental oxygen during high altitude and parachuting operations. The MMOS is primarily employed on board the HH-60, HC-130, and Guardian Angel (GA) rescue Vehicle to treat 1-2 patients for durations of 4-8 hours. The MMOS contains a thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient. The MMOS supports medical devices provided by the user including masks, cannulas, and Bag Valve Mask (BVM) being attached to the flow control patient outlets. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug. The MMOS is portable. The handle on top of the housing, as well as the handles on the left and right side of the front-angled user interface, make the MMOS portable. The MMOS can be carried onboard, tied down, transported and operationally perform on various aircraft and ground vehicles. The MMOS converts liquid oxygen from its insulated container through its heat exchanger into gaseous oxygen and finally the gaseous oxygen is available for distribution from an outlet port on the user interface. After connecting a tube assembly connector of a mask, cannula, and Bag Valve Mask (BVM) to an outlet port, masks, cannulas, and BVMs or other similar medical device (none of these devices is included in the MMOS) the patient can inhale the gaseous oxygen.
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    K Number
    K103324
    Device Name
    PRECISION LIQUID OXYGEN SYSTEM
    Manufacturer
    PRECISION MEDICAL, INC.
    Date Cleared
    2011-04-21

    (160 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Product Code :

    BYJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Medical, Inc. Easy Mate 6 + 6 are intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. These patients would normally receive the oxygen via a nasal cannula. The systems delivers 100% oxygen at different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home.
    Device Description
    The Precision Medical, Inc. Easy Mate 6+6 consists of a Vacuum insulated cryogenic container that includes a pressure relief valve and a pneumatic conserver. The vacuum insulated container allows oxygen to be stored in a liquid state under pressure. When the control valve is positioned to deliver, liquid oxygen inside the container is warmed and changes to gaseous state. The gas is than allowed to be released to the patient at the set rate. The device is intended to be used with a larger stationary liquid Oxygen reservoir, where it is filled by a connection that allows the portable Device to be filled by the larger reservoir. The Precision Medical Inc Easy Mate 6+6 Is a mechanical device containing no electrical components.
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    K Number
    K101272
    Device Name
    MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3
    Manufacturer
    ESSEX INDUSTRIES, INC.
    Date Cleared
    2010-08-20

    (106 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Product Code :

    BYJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MODS is intended to convert liquid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery to a patient at one-half (0.5) to fifteen (15) LPM and fifty (50) psig.
    Device Description
    The MODS has a portable, thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient, and is accompanied by tubing intended for connection to an oxygen mask. The MODS is portable. The MODS houses the thermally insulated stainless steel container, which stores liquid oxygen, and is set on casters while the accompanying unit, the patient distribution kit, is encased with a handle. The MODS converts liquid oxygen (99.9% pure) from the insulated container through a heat exchanger into gaseous oxygen and finally the gaseous oxygen is distributed through the tubing in the accompanying interconnect hose or hose reel assembly and ultimately through the tubing in the accompanying patient distribution kit. After connecting the tube end to an oxygen mask, cannula, simulator ventilator, or other similar medical device (none of these devices is included in the MODS) the patient can inhale the gaseous oxygen. The accompanying patient distribution kit has ten outlet ports that are capable of delivering oxygen to a maximum of ten patients. Multiple patient distribution kits can be used to deliver oxygen to more than patients. The MODS has the capacity to store seventy-five (75) liters of LOX and convert it to a gaseous state. It can be filled using a fill harness and current commercially available LOX storage/filling systems such as a variable gas/liquid (VGL) cylinder. When using the MODS with external LOX cylinders, the system will run indefinitely under normal operating conditions (indoors at room temperature) as long as the LOX cylinders are rotated between each of two MODS external hookup ports. When filled with LOX, the MODS provides an uninterrupted supply of oxygen for delivery to patients at a maximum system flow rate of four hundred fifty (450) liters per minute (LPM) and, when connected to a patient distribution kit, at an individual patient flow rate of one-half (0.5) to fifteen (15) LPM. The nominal operating system pressure of the MODS is two hundred (200) psig and, when connected to a patient distribution kit, the individual hose pressure is fifty (50) psig.
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    K Number
    K081779
    Device Name
    GOLOX-93
    Manufacturer
    RESPIRONICS, INC.
    Date Cleared
    2008-09-19

    (88 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Product Code :

    BYJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GoLox -93 is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside and outside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.
    Device Description
    The GoLox-93 is a double walled vacuum insulated cryogenic vessel designed to hold approximately 1 pound of liquid oxygen at a pressure of 22 psig with heat exchange tubing, relief valves and a pneumatic conserving device housed in a plastic enclosure. Oxygen is stored under low pressure in its liquid state where the pressure is limited by the pressure relief valve. The liquid oxygen is converted to near ambient temperature gaseous oxygen through a system of tubes and warming coils for delivery to patients requiring supplemental oxygen by a single lumen cannula. The device is not intended as life support or life sustaining. The GoLox-93 is a mechanical device and does not contain any electronics or software. The GoLox-93 is designed to be refilled only from Respironics Home Liquefaction Systems.
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    K Number
    K080023
    Device Name
    MODIFICATION TO: SPIRIT
    Manufacturer
    CAIRE, INC.
    Date Cleared
    2008-06-16

    (164 days)

    Product Code
    BYJ, CFR
    Regulation Number
    868.5655
    Why did this record match?
    Product Code :

    BYJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Caire Spirit 300 will provide a source of supplemental oxygen for ambulatory healthcare patients by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device (digital oxygen conserving device-DOCD). The Spirit 300 is neither a life sustaining nor life supporting device.
    Device Description
    The spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure relief valves, a manifold, an electronic printed circuit board conserving device (digital) and a protective case. The dewar has a capacity and capability to store 0.3L of liquid oxygen. The economizer regulator either draws gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below the 20 PSI, the economizer regulator will draw liquid oxygen, from the bottom of the dewar, which must then have to pass through a long vaporizing coil. The economizer regulator assures a longer duration time for the unit, because it allows the gas in the dewar headspace to be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold, dependent on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or diverts a 2L PM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent settings for 1, 1.5, 2, 3, 4 and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosage just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.
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    K Number
    K072723
    Device Name
    RESPIRONICS GOLOX
    Manufacturer
    RESPIRONICS, INC.
    Date Cleared
    2008-03-20

    (176 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Product Code :

    BYJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GoLox USP is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside and outside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.
    Device Description
    The GoLox is a double walled vacuum insulated cryogenic vessel designed to hold approximately 1 pound of liquid oxygen at a pressure of 22 psig with heat exchange tubing, relief valves and a pneumatic conserving device housed in a plastic enclosure. Oxygen is stored under low pressure in its liquid state where the pressure is limited by the pressure relief valve. The liquid oxygen is converted to near ambient temperature gaseous oxygen through a system of tubes and warming coils for delivery to patients requiring supplemental oxygen by a single lumen cannula. The device is not intended as life support or life sustaining. The GoLox USP s designed to be refilled from industry standard liquid oxygen stationary units already cleared and in the marketplace.
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    K Number
    K072011
    Device Name
    COPD LIQUID OXYGEN PORTABLE, MODEL 300P
    Manufacturer
    COPD PARTNERS, INC.
    Date Cleared
    2007-10-18

    (87 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Product Code :

    BYJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COPD Partners Model 300P Liquid Oxygen Portable will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen, and then dispensing it to the patient via an integral electronic conserving device. The Model 300P Liquid Oxygen Portable is neither a life-sustaining nor life-supporting device.
    Device Description
    The COPD Partners' Model 300P is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic Dewar, an economizer regulator, electronic printed circuit board (PCB), an oxygen conserving system, and a protective case. The Dewar has a capacity and capability to store 0.33 liters of liquid oxygen. Dependant on the flow selection setting, the control system either delivers the oxygen to the conserving device or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow method selector. The conserving device has an equivalent setting for 1, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet oxygen gas is delivered in quick pulses beginning at the start of inhalation. The device also has a provision to track the patient's breath rate and in the event of an increase in breath rate, will deliver an increased volume of oxygen. There are two levels of increased volume, one at 4 breath per minute (BPM) over normal breath rate and another at 8 BPM over normal breath rate. The device delivers an extra 16 cc at each of these two thresholds. The COPD Partners Model 300P is transfilled from a commercially available medical grade liquid oxygen source.
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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?
    Product Code :

    BYJ

    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
    K050153
    Device Name
    SPIRIT, MODEL HAS
    Manufacturer
    CAIRE, INC.
    Date Cleared
    2005-04-15

    (81 days)

    Product Code
    BYJ, SPI
    Regulation Number
    868.5655
    Why did this record match?
    Product Code :

    BYJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirit 300 HAS will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing 93% liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. The Spirit 300 HAS is intended to be transfilled only by the In-X Corporation's Home-Away System. The Spirit 300 HAS is neither a life sustaining nor life supporting device.
    Device Description
    The Spirit 300 HAS is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure safety relief valves, a manifold, an electronic printed circuit board conserving device and a protective case. The dewar has a capacity and capability to store 0.3 liters of liquid oxygen. The vaporizer coil warms the oxygen gas to a suitable temperature, as it exits the dewar. Dependant on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent setting for 1, 1.5, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosages just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting. The Spirit 300 HAS is filled from a concentrator liquefaction device.
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