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510(k) Data Aggregation

    K Number
    K223120
    Device Name
    Ventoux VC2; Ventoux VC3
    Manufacturer
    Flight Medical Innovations Ltd.
    Date Cleared
    2024-12-02

    (791 days)

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

    Flight Medical Innovations Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ventoux is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the Ventoux is applicable for adult and pediatric (i.e., infant, child and adolescent) patients who weigh at least 5 kg (11 lbs). The Ventoux is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital environments.
    Device Description
    The Ventoux Ventilator is an electrically powered, microprocessor-controlled multi-parameter ventilator, which can be: Time, Pressure, Flow or Volume triggered; Volume or Pressure controlled; Time or Flow cycled. Manual inflation is allowed, and the Ventoux supports the emergency intake of ambient air which permits the patient to pull ambient air into the breathing circuit in the event of a complete loss of air/gas supply. Volume triggered is based on Inspiratory trig response time ≤100 ms from pressure drop/flow rise to PEEP level. Ventilation is possible in both Invasive and Noninvasive settings. The system can be expanded to include additional parameter monitoring to allow for Sp02, etC02 and Cuff Pressure Control. The Ventoux can be powered by external power (100 – 240 VAC, 50-60 HZ or 10 – 30 VDC) and/or by its two swappable internal Li Ion rechargeable batteries, which provide full operating power the to the ventilator for a minimal operating time of 6 hours when operating on standard ventilation parameters. A comprehensive alarm system is built-in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator. The electrical system is comprised of three primary boards: The main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU. the power board, which holds the power subsystems, and internal communication functions, and the Communication board, which holds internal communication and external communication connectors. The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides a built in PEEP.
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    K Number
    K143035
    Device Name
    Flight 60 Ventilator
    Manufacturer
    FLIGHT MEDICAL INNOVATIONS LTD.
    Date Cleared
    2016-03-30

    (525 days)

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

    FLIGHT MEDICAL INNOVATIONS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLIGHT 60 Ventilator is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the FLIGHT 60 is applicable for adult and pediatic (i.e., infant, child and adolescent) patients, greater than or equal to 5kg (11 1bs). The FLIGHT 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is sutable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
    Device Description
    The FLIGHT 60 Ventilator is an electrically powered, microprocessor controlled ventilator with the following types of ventilatory support: A/CMV Volume or Pressure Control, SIMV Volume or Pressure Control, Pressure Support & SPONT mode with Pressure Support. It can be pressure or time triggered; volume or pressure limited; time, pressure or flow cycled. Manual inflation is possible, and an emergency intake valve allows the patient to pull ambient air into the breathing circuit in the event of a complete loss of supply gas pressure. The FLIGHT 60 may be powered by external power (100 - 240 VACS or 12 - 15 VDC) or by its two internal Li Ion rechargeable batteries. The electrical system is comprised of three primary boards: the Main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU, the Power board, which holds the power subsystems, and internal communication functions, and the Communication board, which holds internal communication and external communication connectors. The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides a built in PEEP.
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    K Number
    K130171
    Device Name
    FLIGHT 60 VENTILATOR
    Manufacturer
    FLIGHT MEDICAL INNOVATIONS LTD.
    Date Cleared
    2014-04-08

    (439 days)

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

    FLIGHT MEDICAL INNOVATIONS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLIGHT 60 Ventilator is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the FLIGHT 60 is applicable for adult and pediatric (i.e., infant, child and adolescent) patients, greater than or equal to 5kg (11 lbs). The FLIGHT 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
    Device Description
    The FLIGHT 60 Ventilator is an electrically powered, microprocessor controlled ventilator with the following types of ventilatory support: ACMV Volume, Pressure or PRVC, SIMV Volume, Pressure or PRVC, PSV/SPONT mode with Pressure Support and Volume Guarantee, Bi-Level (APRV). It can be pressure, flow or time triggered; volume or pressure limited; time, pressure or flow cycled. Manual inflation is possible, and an emergency intake valve allows the patient to pull ambient air into the breathing circuit in the event of a complete loss of supply gas pressure. The FLIGHT 60 may be powered by external power (100 - 240 VACS or 12 - 15 VDC) or by its two internal Li Ion rechargeable batteries, which power the ventilator for up to 12 hours when fully charged. The electrical system is comprised of three primary boards: the Main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU, the Power board, which holds the power subsystem and internal communication functions, and the Communication board, which holds internal communication and external communication connectors. The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides built in PEEP. A comprehensive alarm system is built-in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.
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    K Number
    K120726
    Device Name
    FLIGHT 60 VENTILATOR
    Manufacturer
    FLIGHT MEDICAL INNOVATIONS LTD.
    Date Cleared
    2012-07-06

    (119 days)

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

    FLIGHT MEDICAL INNOVATIONS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLIGHT 60 Ventilator is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the FLIGHT 60 is applicable for adult and pediatric (i.e., infant, child and adolescent) patients, greater than or equal to 5kg (11 lbs). The FLIGHT 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
    Device Description
    The FLIGHT 60 Ventilator is an electrically powered, microprocessor controlled ventilator with the following types of ventilatory support: A/CMV Volume or Pressure Control, SIMV Volume or Pressure Control, Pressure Support & SPONT mode with Pressure Support. It can be pressure or time triggered; volume or pressure limited; time, pressure or flow cycled. Manual inflation is possible, and an emergency intake valve allows the patient to pull ambient air into the breathing circuit in the event of a complete loss of supply gas pressure. The FLIGHT 60 may be powered by external power (100 - 240 VACS or 12 - 15 VDC) or by its two internal Li Ion rechargeable batteries, which power the ventilator for up to 12 hours when fully charged. The electrical system is comprised of three primary boards: the Main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU, the Power board, which holds the power subsystems, and internal communication functions, and the Communication board, which holds internal communication and external communication connectors. The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides a built in PEEP. A comprehensive alarm system is built-in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.
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    K Number
    K111683
    Device Name
    FLIGHT 60 VENTILATOR
    Manufacturer
    FLIGHT MEDICAL INNOVATIONS LTD.
    Date Cleared
    2011-10-31

    (138 days)

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

    FLIGHT MEDICAL INNOVATIONS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLIGHT 60 Ventilator is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the FLIGHT 60 is applicable for adult and pediatric (i.e., infant, child and adolescent) patients, greater than or equal to 10kg (22 lbs). The Flight 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
    Device Description
    The Flight 60 Ventilator is an electrically powered, microprocessor controlled ventilator with the following types of ventilatory support: A/CMV Volume or Pressure Control. SIMV Volume or Pressure Control. Pressure Support & SPONT mode with Pressure Support. It can be pressure or time triggered volume or pressure limited; time, pressure or flow cycled. Manual inflation is possible, and an emergency intake valve allows the patient to pull ambient air into the breathing circuit in the event of a complete loss of supply gas pressure. The Flight 60 may be powered by external power (100 - 240 VACS or 12 -15 VDC) or by its two internal Li Ion rechargeable batteries, which power the ventilator for up to 12 hours when fully charged. The electrical system is comprised of three primary boards the Main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU, the Power board, which holds the power subsystems, and internal communication functions, and the Communication board, which holds internal communication and external communication connectors. The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides a built in PEEP. A comprehensive alarm system is built in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.
    Ask a Question

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