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510(k) Data Aggregation

    K Number
    K161179
    Device Name
    Intelli-Ox
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Date Cleared
    2017-04-13

    (352 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Why did this record match?
    Product Code :

    ECX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intelli-OX is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for all other medical applications, the device is Rx only.
    Device Description
    The Intelli-OX portable oxygen delivery system that supplies Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flow rate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation. Intelli-OX is for emergency use only. For all other medical applications, the device is Rx only. Key specifications include hose barb connection, protective shroud, carrying handle, easy to read content gauge, indexed flow meter, and integrated valve-regulator. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla.
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    K Number
    K161472
    Device Name
    Walk-O2-Bout
    Manufacturer
    ESSEX INDUSTRIES, INC.
    Date Cleared
    2016-11-18

    (175 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Why did this record match?
    Product Code :

    ECX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Walk-O2-Bout® is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and intended for use during MR imaging for static magnetic fields of 3.0 T or less. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
    Device Description
    The Walk-O2-Bout® regulator is designed to be installed on a medical grade aluminum cylinder having 0.750-16 UNF-2B threads; regulate high pressure oxygen from 300-2000 psig nominal; deliver a prescribed amount of oxygen; and be ignition fault resistant. The device consists of: A threaded fill fitting per CGA 540. It shall allow the regulator installed on a cylinder to be refilled to its service pressure. It also allows for the pulling of a vacuum on the system. A pressure regulator section to reduce the pressure from 300-2000 psig to 50 psig nominal. Options of flow selector valves to control the flow between 0 and 25 L/min, at the regulated pressure. A vinyl dipped handle for ease of carrying. A DISS 1240 check valve to deliver 50 psig of oxygen high flow rates of oxygen to ventilators. There are several models offered. In all cases the basic pressure regulator is identical for all models. The models are offered with the following options: Flow rate range of 0 4 L/min (Pediatric), 0 15 L/min and 0 25 L/min (adult) Check Valve Swivel or Fixed Barb Fitting Handle style MR Conditional.
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    K Number
    K153518
    Device Name
    Medipure Oxygen-LC System
    Manufacturer
    PRAXAIR DISTRIBUTION, INCORPORATED.
    Date Cleared
    2016-06-03

    (178 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Why did this record match?
    Product Code :

    ECX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medipure Oxygen-LC System is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is intended for limited duration use, such as would be necessary during patient transport.
    Device Description
    The Medipure Oxygen-LC System is an integrated medical gas delivery system. The Medipure Oxygen-LC System is comprised of the Cavagna MVA2 series oxygen Valve Integrated Pressure Regulator (VIPR) permanently mounted to a large steel cylinder, either K or T size, and protected by a plastic guard. The Medipure Oxygen-LC System is a result of a design modification to the previously cleared Praxair Grab 'n Go Plus System (K132778).
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    K Number
    K143060
    Device Name
    Intelli-Ox
    Manufacturer
    AIR LIQUIDE HEALTHCARE
    Date Cleared
    2015-05-21

    (209 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Why did this record match?
    Product Code :

    ECX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intelli-Ox is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.
    Device Description
    The Intelli-Ox portable oxygen system is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flow rate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only. Key specifications include hose barb connection, protective shroud, carrying handle, easy to read digital content gauge, indexed flow meter, integrated valve-regulator and user instructions. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator.
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    K Number
    K142149
    Device Name
    OXYTOTE INFINITY SERIES VIPR SYSTEMS
    Manufacturer
    WESTERN/SCOTT FETZER CO.
    Date Cleared
    2015-04-17

    (255 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Why did this record match?
    Product Code :

    ECX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For OxyTOTE Infinity: "The OxyTOTE Infinity system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla and cannot be used directly in the MRI bore. The device is intended for limited duration use, such as would be necessary during patient transports. " For Praxair Grab 'n Go Opti: "The Grab 'n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla and cannot be used directly in the MRI bore. The device is intended for limited duration use, such as would be necessary during patient transports. "
    Device Description
    The OxyTOTE Infinity and Praxair Grab 'n Go Opti series VIPR (Valve Integrated Pressure Regulator) Systems provide a package for those who need medical oxygen from portable cylinders. The oxygen regulator, analog pressure gauge, cylinder contents indicator and gas supply valve are combined, and permanently attached to the gas cylinder as one system. This design allows medical personnel the ability to provide patient care and treatment without the need to mount a conventional separate regulator. The regulator reduces cylinder pressure and provides 10 user selectable flow rates (½, 1, 1½, 2, 3, 4, 6, 8, 15, 25 LPM) of USP oxygen that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides flow rates up to 100 LPM oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. Key features include; hose barb connection, protective shroud, carrying handle, cylinder content gauge, indexed flow meter, shutoff valve, and AUX (DISS-1240) connection.
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    K Number
    K132778
    Device Name
    GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
    Manufacturer
    PRAXAIR HEALTHCARE SERVICES
    Date Cleared
    2014-07-07

    (305 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Why did this record match?
    Product Code :

    ECX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Grab 'n Go system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is MR Conditional, and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. The device is intended for limited duration use, such as would be necessary during patient transports.
    Device Description
    The Grab 'n Go Plus / Grab 'n Go Digital (collectively referred to as the Grab 'n Go system) integrated delivery system supplies oxygen using a device comprising an integrated valve-regulator with pressure gauge, flow meter and oxygen gas cylinder with protective shroud all integrated into a single unit. The device is able to provide a range of user selectable flow settings, including low and high flows that may be clinically appropriate for certain classes of patients. An additional DISS connection provides standard 50-PSI oxygen gas delivery. The optional digital pressure gauge (Grab 'n Go Digital) provides both audible and visual low contents alerts and alarms as well as estimated time of use. The system must only be used by trained medical personnel.
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    K Number
    K131386
    Device Name
    EZ-OX PLUS GENERATION II
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA
    Date Cleared
    2014-03-14

    (304 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Why did this record match?
    Product Code :

    ECX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EZ-OX Plus Generation II is an integrated portable oxygen delivery system intended to provide supplemental oxygen to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the EZ-OX Plus Generation II is for emergency use only. For all other medical applications, the device is Rx only.
    Device Description
    The EZ-OX Plus Generation II portable oxygen system is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical D and E-Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flowrate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 40 L/min oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the EZ-OX Plus Generation II is for emergency use only. For all other medical applications, the device is Rx only. Key specifications include hose barb connection, protective shroud, carrying handle, easy to read content gauge, indexed flow meter, integrated valve-regulator and usage chart label with safety instructions. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator.
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    K Number
    K101792
    Device Name
    LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706
    Manufacturer
    LINDE GAS NORTH AMERICA LLC
    Date Cleared
    2011-03-18

    (263 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Why did this record match?
    Product Code :

    ECX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIV is an inteqrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults.. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MR1 systems up to 3.0T. Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
    Device Description
    The Linde Integrated Valve® ("LIV") is a portable oxygen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of userselectable flow settings is available, inclúding low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50 psig oxygen delivery, while an optional bed hanger allows the LV to be readily attached to a bed. The LV is suitable for use in all healthcare settings including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.
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    K Number
    K063354
    Device Name
    LINDE INTEGRATED VALVE (LIV)
    Manufacturer
    LINDE GAS THERAPEUTICS
    Date Cleared
    2007-04-17

    (162 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Why did this record match?
    Product Code :

    ECX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIV is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall! be rah Uized or otherwise secured to prevent falling and rolling.
    Device Description
    The Linde Integrated Valve™ ("LIV") is a portable oxyqen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of user-selectable flow settings is available, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50psig oxygen delivery, while an optional bed hanger allows the LIV to be readily attached to a bed. The LIV is suitable for use in all healthcare settings, including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.
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    K Number
    K062300
    Device Name
    OX-SOX, MODEL C, D, E,
    Manufacturer
    PATTIENT SAFETY INNOVATIONS, LLP
    Date Cleared
    2006-11-27

    (111 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Why did this record match?
    Product Code :

    ECX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ox-Sox is designed to fit over and clearly identify "E" Oxygen cylinders, both in healthcare facilities and for home use. The device is for use with gas cylinders containing oxygen.
    Device Description
    The Ox-Sox is designed to fit over and clearly identify "E" Oxygen cylinders.
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