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510(k) Data Aggregation

    K Number
    K112852
    Device Name
    BABI PLUS NEONATAL RESUSCITATION BAG
    Manufacturer
    A PLUS MEDICAL
    Date Cleared
    2012-01-13

    (87 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    A PLUS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.
    Device Description
    Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.
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    K Number
    K110471
    Device Name
    BABI PLUS INFANT NASAL CANNULA SYSTEM
    Manufacturer
    A PLUS MEDICAL
    Date Cleared
    2011-10-07

    (231 days)

    Product Code
    BZD, C10
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    A PLUS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.
    Device Description
    Single patient use nasal cannula offered in 8 different sizes which have been specifically designed for patents ≤ 10 Kg. The device includes a short length of 10 mm corrugated tubing allowing connection to a variety of devices. The device also provides a means to monitor delivered pressure at the nasal prong.
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    K Number
    K110383
    Device Name
    BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
    Manufacturer
    A PLUS MEDICAL
    Date Cleared
    2011-08-01

    (172 days)

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

    A PLUS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single patient use device intended for neonate, infant or child with a body mass of less than 10 Kg requiring a pressure limitation system to eliminate excessive pressure should an obstruction occur between gas supply and exhalation port during continuous gas flow therapy up to 12 liters per minute in hospital critical care unit.
    Device Description
    The Book Plus" single patient use Pressure Limitation Manifold is an accessory to the Book Plus" Infant Nasal Cannula System cleared for sale in K093716. The device is designed to protect patients up to 10 Kg from excessive pressure should a downstream occlusion occur in a positive pressure breathing system. The device is offered in 10 cm H2O and 15 cm HsO pressure relief valve configurations. The device is supplied with oxygen senor port, fresh gas inlet and a 1 meter length of gas supply tubing. The device connector molded in a rigid plastic to which a pressure relief valve is mounted on the vertical axis, the fresh gas inlet and oxygen senror port are located adgacent to each other on the hporzontial axis. The device relieves pressure cause by an occlusion before the expiratory port and automatically resets upon correction of the occlusion. The outlet port of the device is a 22 mm inside diameter connection in compliance with ISO 5356-1, Version 3.
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    K Number
    K102377
    Device Name
    VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0
    Manufacturer
    A PLUS MEDICAL
    Date Cleared
    2010-11-18

    (90 days)

    Product Code
    CAP
    Regulation Number
    868.2600
    Why did this record match?
    Applicant Name (Manufacturer) :

    A PLUS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for use where monitoring airway pressure is desired by providing a visual indication of airway pressure and may be used on all patient populations in the hospital, post-hospital and home care environments Intended for use where monitoring airway pressure is desired. This device provides a visual indication of airway pressure and may be used on all patient populations in the hospital, pre-hospital, post-hospital and home care environments.
    Device Description
    Single patient use mechanical pressure manometer indicator compresses a spring to a position where the force exerted by the gas equals the force exerted by the compressed spring combinations and graduated marking on individual housings allow the device to be offered in 0 - 60 cm H2O and 0 - 15 cm H2O pressure ranges.
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    K Number
    K093716
    Device Name
    BABI PLUS INFANT NASAL CANNULA SYSTEM
    Manufacturer
    A PLUS MEDICAL
    Date Cleared
    2010-05-13

    (162 days)

    Product Code
    BZD, 868
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    A PLUS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.
    Device Description
    Single patient use nasal cannula offered in 8 different sizes which have been specifically designed for patents ≤ 10 Kg. The device includes a short length of 10 mm corrugated tubing allowing connection to a variety of devices. Pre-conditioned gas (heat, moisture, flow and oxygen concentration) is provided to the device's inspiratory circuit. The gas is channeled to the nasal cannula for inhalation. Expired gas is channeled away from the nasal cannula and eventually is vented to the surrounding environment. The device also includes a pressure monitor nasal prong (proximal airway) pressure.
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    K Number
    K092687
    Device Name
    VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER
    Manufacturer
    A PLUS MEDICAL
    Date Cleared
    2009-11-23

    (83 days)

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

    A PLUS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single patient use non self-inflating manual resuscitator for use in hospital and transport to temporary ventilate neonate, infant and pediatric patients. The pressure manometer in this product provides a visual indication of airway pressure during ventilation.
    Device Description
    Single patient use hyperinflation bag with pressure manometer offered in 0.25, 0.50 and 1.0 liter ventilation bag sizes. End user manipulates gas flow and respiratory rate and exhalation port to control amount of gas, inspiratory pressure supplied to the patient. Each device has an integrated 0 - 60 cm H2O pressure manometer.
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    K Number
    K090317
    Device Name
    BABI*PLUS BUBBLE PAP VALVE
    Manufacturer
    A PLUS MEDICAL
    Date Cleared
    2009-05-20

    (100 days)

    Product Code
    BYE
    Regulation Number
    868.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    A PLUS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Babi*Plus Bubble PAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 Kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions.
    Device Description
    Single patient use water seal positive end expiratory pressure device.
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