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510(k) Data Aggregation

    K Number
    K042161
    Device Name
    ANTI-SNORING/SLEEP APNEA DEVICE
    Date Cleared
    2004-10-27

    (78 days)

    Product Code
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    RJ & VK **BIRD **PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MDSA is an intraoral device (mandibular repositioning) for the treatment of snoring and sleep apnea. The device is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea. Prescription Device Custom-Made Mandibular Repositioning Device Reduce Snoring Treat Mild to Moderate Obstructive Sleep Apnea Single Patient / Multi-Use Not for Use in Persons Younger than 18 Years of Age Home or Sleep Laboratory Environment
    Device Description
    The MDSA is an intraoral dental device for the treatment of snoring and sleep apnea. The MDSA is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea. The MDSA is a prescription Custom Made titratable mandibular repositioning device for the dental treatment of patients suffering snoring and obstructive sleep apnea. Patient's dental impressions must be used to construct the device. The MDSA is a 2-part device. With an upper containing the hook component in the front that when in the patient's mouth engages a shelf in the lower. The MDSA is supplied with an Adjuster Key, which is used to move the hook in the upper to advance the lower jaw forward and accordingly advance the mandible and tongue thereby improving patency of the airway, decrease air turbulence and aid improvement of obstructive sleep apnea. The MDSA can be molded with commonly available materials used by Dental Laboratories either Hard Acrylic and ball clasps or Double Laminate (Hard /Soft) Functional mouthguard materials for the construction of the device. A Bite Registration taken at the same time as the impressions facilitates the Laboratory technician correctly locating the components during construction. Because of its unique design when incitu the patient has full lateral movement and the device can be titrated to the individual patients needs. The advantage of the MDSA is that its construction can be easily performed by a normally qualified Laboratory Technician using standard Laboratory Equipment. This affords a saving in costs to the end user. The MDSA components are made from Medical Grade 316 Stainless Steel. The Hook/Screw component is welded into its outer housing to ensure security during use.
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    K Number
    K032451
    Device Name
    BIRD TBIRD VELA VENTILATOR
    Date Cleared
    2004-03-17

    (219 days)

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

    **BIRD **PRODUCTS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TBird VELA Ventilator is intended to provide continuous or intermittent mechanical ventilatory support for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following general types of ventilatory support, as prescribed by an attending physician: - Positive pressure ventilation . - Assist/Control, SIMV, CPAP modes of ventilation . The ventilator is suitable for use in institutional and transport settings. It is not intended for use as an emergency medical transport ventilator.
    Device Description
    The TBird VELA Ventilator employs a turbine gas delivery system along with microprocessor control to provide support for pediatric to adult patients. Capable of delivering clinically advanced modes of ventilation like Pressure Support with an internal battery or AC power the TBird VELA Ventilator has an extensive patient range. The TBird VELA Ventilator ventilator pneumatic system is an electromechanical system comprised of four major subsystems, each containing several components. These systems include the flow delivery system, the exhalation system, the safety system and the inspiratory hold valve. This electromechanical system controls all inspiratory flow to the patient. The exhalation system controls the flow of gas from the patient's lungs during the exhalation phase. The mechanical safety system ensures that the patient can breath spontaneously from room air and that the patient pressure is limited to a maximum value in the event of a ventilator malfunction. When activated, the inspiratory hold valve blocks flow between the flow delivery system and the patient. The TBird VELA Ventilator ventilator electronic system is comprised of several subsystems, each containing numerous components. These subsystems include the Graphical User Interface System, the Power System, the Main Controller System, Exhalation, and Flow Delivery systems. The Display System is comprised of SVGA and Touchscreen. The Main Controller System is comprised of three Pressure Transducers, an Analog-to-Digital Converter, two Digital-to-Analog Converters, the Input-Output Processor, Solenoid Valves, and the Watchdog and Hardware Fault Monitors. The Power System conditions and controls energy from the AC input, the internal battery, and the option of external battery pack. The ventilator operates from this source, as well as recharging the internal battery.
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    K Number
    K022674
    Device Name
    BIRD AVEA VENTILATOR
    Date Cleared
    2002-11-06

    (86 days)

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

    **BIRD **PRODUCTS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. The AVEA is indicated for the delivery of air, oxygen or a helium-oxygen combination (Heliox).
    Device Description
    The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic breathing gas delivery that provides for neonatal through adult patients. Its module provides maximum flexibility with simple operator interaction. It has a range of user interface interaction, membrane keys and a dial for changing settings and operating parameters. It also has an internal gas delivery system with servo controlled active inhalation and exhalation functions. The AVEA may be configured as a conventional ventilator or noninvasive positive pressure ventilator (NPPV). It has been designed to function using most commonly available accessories.
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    K Number
    K013642
    Device Name
    AVEA
    Date Cleared
    2002-05-22

    (198 days)

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

    **BIRD **PRODUCTS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AVEA is intended to provide continuous respiratory support in an institutional health care environment. It may be used on adult, pediatric, and neonatal patients. Properly trained clinical personnel, under the direction of a physician should only operate it.
    Device Description
    The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its user interface module provides maximum flexibility with simple operator interaction. It has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for interaction, membrane keys and a dial for changing settings and operating parameters. It also has an internal gas delivery system with servo controlled active inhalation and exhalation functions. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed to function using most commonly available accessories.
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    K Number
    K020730
    Device Name
    ORION NASAL CPAP SYSTEM
    Date Cleared
    2002-05-22

    (77 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BIRD **PRODUCTS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Orion Nasal CPAP System is intended for treatment of Obstructive Sleep Apnea (OSA). Obstructive Sleep Apnea is defined as the absence of air movement in ten seconds during sleep. Obstructive Sleep Apnea is usually diagnosed through a sleep study. The study obtains the optimum level of pressure required to maintain airway pressure to the obstructed airway. The positive pressure allows the airway to stay open. The Orion Nasal CPAP System is intended only for spontaneously breathing patients.
    Device Description
    The Orion Nasal CPAP System is intended to provide continuous positive airway pressure for the care and treatment of individuals suffering from obstructive sleep apnea. The positive pressure is clinician-adjustable within the designed operating range, and a clinicianadjustable time allows at timed rise to the set pressure. The user controls are limited to an On/Off switch and the optional pre-set time rise to the set pressure. This device is designed to be used with a 22-millimeter, smooth-bore air delivery hose and user-selected nasal or face mask. The Orion consists of a plastic enclosure that surrounds a power supply, impeller and motor, microprocessor, motor controller, display and switch inputs.
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    K Number
    K020746
    Device Name
    BIRD TBIRD VELA VENTILATOR
    Date Cleared
    2002-04-22

    (46 days)

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

    **BIRD **PRODUCTS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TBird VELA Ventilator is intended to provide continuous or intermittent mechanical ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following general types of ventilatory support, as prescribed by an attending physician: - Positive pressure ventilation . - Assist/Control, SIMV, CPAP modes of ventilation . The ventilator is suitable for use in institutional and transport settings. It is not intended for use as an emergency medical transport ventilator.
    Device Description
    The TBird VELA Ventilator employs a turbine gas delivery system along with microprocessor control to provide support for pediatric to adult patients. Capable of delivering clinically advanced modes of ventilation like Pressure Support with an internal battery or AC power the TBird VELA Ventilator has an extensive patient range. The TBird VELA Ventilator ventilator pneumatic system is an electromechanical system comprised of four major subsystems, each containing several components. These systems include the flow delivery system, the exhalation system, the safety system and the inspiratory hold valve. This electromechanical system controls all inspiratory flow to the patient. The exhalation system controls the flow of gas from the patient's lungs during the exhalation phase. The mechanical safety system ensures that the patient can breath spontaneously from room air and that the patient pressure is limited to a maximum value in the event of a ventilator malfunction. When activated, the inspiratory hold valve blocks flow between the flow delivery system and the patient. The TBird VELA Ventilator ventilator electronic system is comprised of several subsystems, each containing numerous components. These subsystems include the Graphical User Interface System, the Power System, the Main Controller System, Exhalation, and Flow Delivery systems. The Display System is comprised of three Alarm Setpoint Displays, seven Control Setpoint Displays, up to forty-eight Message Display characters, up to twentyfive Discrete Indicators, and a bargraph style Manometer. The Main Controller System is comprised of three Pressure Transducers, an Analog-to-Digital Converter, two Digital-to-Analog Converters, the Input-Output Processor, Solenoid Valves, and the Watchdog and Hardware Fault Monitors. The Power System conditions and controls energy from the AC line input, the internal battery, and the optional external battery pack. When energy is available from the AC line, the ventilator operates from this source, as well as recharging the internal battery.
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    K Number
    K012501
    Device Name
    H.M.T. ACUPUNCTURE NEEDLE
    Date Cleared
    2001-12-11

    (130 days)

    Product Code
    Regulation Number
    880.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUMMING**BIRD **MEDICAL TECHNOLOGY, L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Hummingbird brand acupuncture needles are defined as prescription devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
    Device Description
    Hummingbird brand acupuncture needles are sterile, single use only. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
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    K Number
    K003770
    Device Name
    BIRD TBIRD LEGACY VENTILATOR
    Date Cleared
    2000-12-15

    (9 days)

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

    **BIRD **PRODUCTS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K990856
    Device Name
    HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
    Date Cleared
    2000-01-11

    (302 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BIRD **PRODUCTS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The nasal CPAP unit is intended for treatment of adult Obstructive Sleep Apnea (OSA). Obstructive sleep apnea is defined as the absence of air movement for ten seconds during sleep. Obstructive sleep apnea is usually diagnosed by a sleep study. The study obtains the optimum level of pressure required to maintain an unobstructed airway, the positive pressure allows the is ve or prosuropen. The nasal CPAP unit is intended only for spontaneously breathing adult patients.
    Device Description
    The SoftAire Nasal CPAP System is intended to provide continuous positive airway pressure for the care and treatment of individuals suffering from obstructive sleep apnea. The positive pressure is clinician adjustable within the designated operating range and a clinician adjustable timer will allow timed rise to pressure ("Ramp" mode). The user controls will be limited to an on/off switch and option of using the timed pressure rise. This product is designed to be used with a 22 millimeter (smooth bore) tube air delivery system and user selected nasal mask. This mask is not marketed by Bird. Power will be provided by AC to DC adapter s which accommodate a variety of input voltages and frequencies. This adapter will plug into a 12 VDC connector on the side of the unit. The SoftAire Nasal CPAP System does not utilize an actively controlled exhalation valve. The patient circuit consists of two essential parts: a large-bore tube from the ventilator to the patient and a required exhaust port. The exhaust is an orifice which may be part of the adapter between the tubing an the patient mask, or may be an orifice which is part of the patient mask.
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    K Number
    K993449
    Device Name
    BIRD V.I.P. GOLD/STERLING
    Date Cleared
    1999-12-20

    (69 days)

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

    **BIRD **PRODUCTS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VIP Bird Gold and VIP Sterling are ventilators intended to treat respiratory failure or respiratory insufficiency, in neonatal, infant and pediatric patients. The ventilators are intended for institutional use only, and not for emergency medical transport or home use.
    Device Description
    The V.I.P Bird ventilator is a self-contained unit, combining an advanced pneumatic system with microprocessor -based technology. The result is a state-of-the-art ventilator system capable of providing excellent patient monitoring. Packaged in a compact lightweight unit, the V.I.P. Bird Gold/Sterling will incorporate all previous function of the V.I.P. Bird and the addition of Pressure Control mode of ventilation with Variable Rise Time, Volume Assured Pressure Support, Flow Triggering in Volume modes and a decelerating waveform. Other enhancements include expanded control setting range for Tidal Volume, improved resolution for the Inspiratory Time and Peak Flow controls. These specifications also include the volume monitoring functions of the Partner IIi.
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