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510(k) Data Aggregation

    K Number
    K072926
    Device Name
    HELONTIX VENT
    Manufacturer
    LINDE GAS THERAPEUTICS
    Date Cleared
    2008-10-15

    (366 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    LINDE GAS THERAPEUTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Helontix Vent is designed to deliver helium/oxygen mixtures to spontaneously breathing patients via a facemask with or without pressure support. The system is designed for facility use and should only be used under the orders of a clinician. The Helontix Vent delivery system is not intended as a life support device and is not intended for intubated patients.
    Device Description
    The Helontix vent is a stand alone assembly to deliver heliox or oxygen. To accomplish this, the Helontix vent consists of a device with a built in battery and a trollev with mounted oxygen and Heliox gas cylinders. When connected to O2 and Heliox (79%He, 21%O2) the Helontix vent delivers a mixture of oxygen and helium in the required fraction to the patient who can breathe over a mask that is connected to the device via a hose system. The Helontix vent interacts with the user via a user interface, i.e. a display, diodes, speaker, several keys and a control wheel. The device informs the user on the screen about set values, monitored values, alarms, ventilation modes and the navigation through the menus while the user can choose the ventilation mode, set values, silence alarms and navigate through menus by using keys and control wheel. The Helontix vent is device designed for Non-invasive Positive Pressure Ventilations (NPPV) for spontaneous breathing patients. The inspiration flow can be either triggered by the patient with a surplus support of pressure (pressure support mode, PSM, 3-30mbar@peak flow 160SLPM) or alternatively a constant flow from 5-60 SLPM without a pressure support (constant flow mode, CFM) can be selected. The breathing circuit, mask and filter used are purchased previously cleared devices.
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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?
    Applicant Name (Manufacturer) :

    LINDE GAS THERAPEUTICS

    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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