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510(k) Data Aggregation

    K Number
    K131881
    Device Name
    OMBRA TABLE TOP COMPRESSOR
    Manufacturer
    TRUDELL MEDICAL INTL.
    Date Cleared
    2013-10-24

    (121 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUDELL MEDICAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ombra® Table Top Compressor is designed to deliver compressed air to a jet or pneumatic nebulizer. This compressor may be used with adult, child or pediatric patients. The Ombra* Table Top Compressor is a medical device, and should only be used as directed by your healthcare professional. The intended environments for use include the home, hospitals and clinics.
    Device Description
    The Ombra* Table Top Compressor provides a source of compressed air for use with jet nebulizers. The device is a motor-driven compressor, housed in a plastic case with rubber skids. It operates from 120V/60Hz. It is supplied with several replaceable air filters. The Ombra* Table Top Compressor is intended for adult, child and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.
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    K Number
    K123400
    Device Name
    AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
    Manufacturer
    TRUDELL MEDICAL INTL.
    Date Cleared
    2013-05-16

    (192 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUDELL MEDICAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aerobika* Oscillating Positive Expiratory Pressure device is intended for use as a Positive Expiratory Pressure (PEP) device. The Aerobika* Oscillating PEP device may also be used simultaneously with nebulized aerosol drug delivery. The device is intended to be used by patients capable of generating an exhalation flow of 10 lpm for 3 – 4 seconds.
    Device Description
    The Aerobika* Oscillating Positive Expiratory Pressure (PEP) device is indicated as a single patient use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when a patient exhales through the device. The Aerobika* device may be used simultaneously with aerosol drug delivery from a nebulizer.
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    K Number
    K123614
    Device Name
    SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
    Manufacturer
    TRUDELL MEDICAL INTL.
    Date Cleared
    2013-03-11

    (108 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUDELL MEDICAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Solarys* Ventilator Aerosol Delivery System (AS) is a nebulizer intended to deliver prescribed aerosolized medication to mechanically ventilated pediatric and adults patients able to use an Endotracheal Tube equal to or greater than 4.5 mm in diameter. The device is designed to operate in-line with ventilator circuits and mechanical ventilators in acute and sub-acute care environments.
    Device Description
    The Solarys* Ventilator Aerosol Delivery System (AS) is a single-use (disposable) continuous nebulizer system designed for use with mechanically ventilated patients to aerosolize physician-prescribed medications for inhalation.
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    K Number
    K112010
    Device Name
    AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)
    Manufacturer
    TRUDELL MEDICAL INTL.
    Date Cleared
    2012-07-11

    (363 days)

    Product Code
    NVP
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUDELL MEDICAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K110136
    Device Name
    RESPICHAMBER VALVED HOLDING CHAMBER
    Manufacturer
    TRUDELL MEDICAL INTL.
    Date Cleared
    2011-04-18

    (90 days)

    Product Code
    NVP
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUDELL MEDICAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RespiChamber Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
    Device Description
    The RespiChamber* Valved Holding Chamber (VHC) is a device used for the administration of metered dose inhaler medication to a spontaneously breathing patient. By means of a one-way valve, medication particles are held in the chamber for several seconds after actuation has occurred enabling inhalation by the patient. The device is designed to minimize delivery of the larger particles of aerosolized medication, which may otherwise lodge in the mouth, throat and upper airway, while allowing the smaller therapeutic particles to be inspired.
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    K Number
    K090065
    Device Name
    AEROCHAMBER MINI VENTILATION CHAMBER
    Manufacturer
    TRUDELL MEDICAL INTL.
    Date Cleared
    2009-04-09

    (90 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUDELL MEDICAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AeroChamber mini Ventilation Chamber is a single patient, disposable device, intended to be used for the administration of metered dose inhaler medication prescribed by a physician or health care professional. The device is intended for use with patients on mechanical ventilation via resuscitation bag or ventilator circuit. The intended environments for use include the home, hospitals and clinics.
    Device Description
    The AeroChamber mini Ventilation Chamber is a single patient, disposable device, intended to be used for the administration of metered dose inhaler medication prescribed by a physician or health care professional.
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    K Number
    K080926
    Device Name
    AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER
    Manufacturer
    TRUDELL MEDICAL INTL.
    Date Cleared
    2008-08-12

    (132 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUDELL MEDICAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device, intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics. The device may be used with a compressor capable of delivering a flow of 2.75 to 8 lpm under an operating pressure of 15 to 50 psi.
    Device Description
    AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device.
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    K Number
    K070674
    Device Name
    AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR
    Manufacturer
    TRUDELL MEDICAL INTL.
    Date Cleared
    2007-04-11

    (30 days)

    Product Code
    NVP
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUDELL MEDICAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AeroChamber Plus® aVHC with Flow-Vu® IFI is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
    Device Description
    Not Found
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    K Number
    K053605
    Device Name
    AEROECLIPSE II BREATH ACTUATED NEBULIZER
    Manufacturer
    TRUDELL MEDICAL INTL.
    Date Cleared
    2006-02-27

    (62 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUDELL MEDICAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AeroEclipse® II Breath Actuated Nebulizer is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
    Device Description
    AeroEclipse® II Breath Actuated Nebulizer
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    K Number
    K052332
    Device Name
    AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER
    Manufacturer
    TRUDELL MEDICAL INTL.
    Date Cleared
    2005-09-21

    (26 days)

    Product Code
    NVP
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUDELL MEDICAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AeroChamber Z-STAT Plus™ Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
    Device Description
    Not Found
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