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510(k) Data Aggregation

    K Number
    K031383
    Device Name
    MODEL 780
    Manufacturer
    HUDSON RESPIRATORY CARE, INC.
    Date Cleared
    2003-07-07

    (67 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUDSON RESPIRATORY CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier; the heated wires are intended to minimize condensation in the ventilator tubing.
    Device Description
    Breathing circuit that is intended to administer medical gases to a patient. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y piece. The heated wires are intended to minimize condensation in the ventilator tubing.
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    K Number
    K011125
    Device Name
    NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
    Manufacturer
    HUDSON RESPIRATORY CARE, INC.
    Date Cleared
    2001-06-13

    (61 days)

    Product Code
    CAT
    Regulation Number
    868.5340
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUDSON RESPIRATORY CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011134
    Device Name
    OXYGEN SUPPLY TUBING, MODEL 1115
    Manufacturer
    HUDSON RESPIRATORY CARE, INC.
    Date Cleared
    2001-06-13

    (61 days)

    Product Code
    BYX
    Regulation Number
    868.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUDSON RESPIRATORY CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010402
    Device Name
    SMOOTH-FLO CIRCUIT
    Manufacturer
    HUDSON RESPIRATORY CARE, INC.
    Date Cleared
    2001-03-14

    (30 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUDSON RESPIRATORY CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001213
    Device Name
    CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60
    Manufacturer
    HUDSON RESPIRATORY CARE, INC.
    Date Cleared
    2000-11-03

    (203 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUDSON RESPIRATORY CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993355
    Device Name
    HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
    Manufacturer
    HUDSON RESPIRATORY CARE, INC.
    Date Cleared
    2000-05-24

    (231 days)

    Product Code
    BTT, FEB
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUDSON RESPIRATORY CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When used with Hudson RCI CONCHATHERM heaters and Hudson RCI ventilator circuits, the 385-40 While Column provides heated humidification for patients with and without an artificial airway in place. When used with the Hudson RCI CONCHATHERM heater and Cat. No. 385-40 column the 780-40, 780-41, 780-42, 780-43 circuit provides a gas conduit from the ventilator to the patient and back to the ventilator, and includes both conventional and heated wire circuit modes of neouatal ventilation.
    Device Description
    Not Found
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    K Number
    K994352
    Device Name
    SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
    Manufacturer
    HUDSON RESPIRATORY CARE, INC.
    Date Cleared
    2000-03-22

    (90 days)

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

    HUDSON RESPIRATORY CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Side Draft Neb-U-Mist Nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. This device is for single patient use and is not intended for reprocessing. The Hudson RCI Side Draft Neb-U-Mist® Nebulizer is a non-sterile, single patient use. Disposable Small Volume Nebulizer device designed to be used for intermittent aerosol therapy to deliver hydrating agents or other prescribed inclutions for inhalation. The Hudson RCI Side Draft Neb-U-Mist® Nebulizers intended to treat bronchial spasms, or airway obstruction, associated with diseases such as asthma, chronic bronchitis, and emphysema.
    Device Description
    The Hudson RCI Side Draft Neb-U-Mist® Nebulizer employs the Bernoulli Effect in order to transform the solution of liquid medication into tiny particles that can in order to transform the belation on the Bernoulli Effect - the phenomenon be carried in a gad mixture to with increased stream velocity in a fluid – causes the lowering of lateral pressure around the stream of gas to draw liquid up a the lowering of lateral peaches the top of the capillary tube it comes into contact with the stream of gas, it is then shattered into small particles (approximately 3 to 5 microns). These particles are then forced against a baffle (approximately o to o microne) of the particles that will be delivered to the patient that rouses the larger particles. The larger particles settle inside the Nebulizer by removing the largor particles, returning mist to liquid to repeat nebulization process. The smaller particles are then administered as the patient inhales.
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    K Number
    K964719
    Device Name
    HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
    Manufacturer
    HUDSON RESPIRATORY CARE, INC.
    Date Cleared
    1997-02-21

    (88 days)

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

    HUDSON RESPIRATORY CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator with pressure monitoring port is disposable medical device intended for use on patients requiring temporary augmentation of ventilation, with or without supplemental oxygen delivery, during episode of acute ventilatory failure or insufficiency, who, because of their weight or other factors, require monitoring of peak inspiratory pressure. The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator provides a means of temporary ventilation until the patient either regains the ability to spontaneously ventilate, or until other life sustaining measures may be implemented. Resuscitators may also be used as a "back-up" ventilation system in the event of mechanical ventilator failure, or may be used to hyper oxygenate or hyperventilate a patient prior to endotracheal tube suctioning or endotracheal intubation. The pressure monitoring port component of the device permits the monitoring of peak inspiratory pressures in those patients where PIP is a concern.
    Device Description
    The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator is a disposable, single patient use, medical device which temporarily augments ventilation in patients during ventilatory insufficiency or ventilatory failure. As is the case with the device in the original submission, this modified resuscitator may be used in the hospital, in physician office, outpatient care facilities, extended care facility, home, emergency medical services and patient transport. The only difference between the original device and this modified version is the presence of a pressure monitoring port located on the non-rebreathing valve component of the finished device assembly.
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    K Number
    K961150
    Device Name
    DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA
    Manufacturer
    HUDSON RESPIRATORY CARE, INC.
    Date Cleared
    1996-09-10

    (172 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUDSON RESPIRATORY CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hudson RCI Gas Sampling Oxygen Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.
    Device Description
    The Hudson RCI nasal cannula with gas sampling port has bifurcated nares that channel oxygen delivery through both nasal prongs while allowing sampling of the patient's exhaled gas from both nasal prongs. Oxygen is delivered to the Cannula during all phases of ventilation through the base of the cannula and is directed through the lower halves of each nasal pronq into the nasal pharynx. During exhalation, oxygen continues to flow into the nasal pharynx through these lower pronq halves. When the gas sampling line is connected to an expiratory gas monitor, a small amount of gas is continuously withdrawn from the nasal pharynx through the upper halves of both nasal prongs. Part of this gas exits one side of the cannula and is routed via a small-bore gas sampling line to the expired gas monitor.
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    K Number
    K961914
    Device Name
    BACTERIA/VIRAL FILTER
    Manufacturer
    HUDSON RESPIRATORY CARE, INC.
    Date Cleared
    1996-08-14

    (89 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUDSON RESPIRATORY CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
    Device Description
    The Hudson RCI Cat. No. 1605 Bacteria / Viral Filter is a disposable, single patient use breathing filter consisting of a gas-permeable filter medium captured between two clear plastic housings. When the Hudson RCI Cat. No. 1605 Bacteria / Viral Filter is inserted into a breathing circuit, the respiratory gas passes through the electrostatically-charged hydrophobic filter medium within the filter. The medium traps bacteria and viruses carried within the airstream.
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