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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    WESTERN/SCOTT FETZER CO.

    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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