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510(k) Data Aggregation

    K Number
    K032922
    Device Name
    CLARISSA INFANT NCPAP CANNULA
    Manufacturer
    AIRWAYS LTD., INC.
    Date Cleared
    2004-09-22

    (366 days)

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

    AIRWAYS LTD., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clarissa Infant nCPAP Cannula is intended to be used for the administration of continuous positive airway pressure (CPAP) on continuously monitored neonatal and infant patients in the hospital/institutional environment.
    Device Description
    The Clarissa Infant nCPAP Cannula is a soft hollow medical grade silicone coaxial pouch with protruding silicone cannula tips that fit into the infant's nares. Continuous flow circulates through the coaxial pouch under positive pressure from which the patient breathes via the cannula. The distal end of the pouch has a swivel adapter with three external ports and one external port. One external port is for pressure and the other two are in-flow and out-flow ports which are bi-directional. The internal port on the swivel adapter is the connection for the internal tube leading to the proximal cannula to minimize dead space.
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    K Number
    K951944
    Device Name
    NASALFLAIR
    Manufacturer
    AIRWAYS LTD., INC.
    Date Cleared
    1997-03-28

    (702 days)

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

    AIRWAYS LTD., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Airways Nasalflair is intended for use as a therapeutic device under the direction of qualified medical personnel. Nasalflair is used by patients who have been prescribed nCPAP as a treatment for Sleep Apnea. Nasalflair may be used with CPAP and flow generators capable of generating 20 t 2 cmH20 pressure via a 22mm I.D. main flow air supply tube.
    Device Description
    Nasalflair is a device that fits into patient's nares in a way that makes a substantially airtight seal, which facilitates the delivery of nasal Continuous Positive Airway Pressure (nCPAP) The device has two cannulae that fit into the patient's therapy. nares. Surrounding the tip of each cannulae are cuffs that inflate to create a seal around the cannulae just inside the The cuffs are inflated through an aperture in the nares. cannulae wall with the same air and pressure the patient is Pressure inside the inflated cuffs is equal to the breathing. pressure in the airway, thereby providing an adequate airtight seal. The cuffed cannula tips are elliptical, and swivel for They snap onto and off of the J pieces maximum patient comfort. to facilitate cleaning and economical replacement. The J pieces They also have a fixed have a tab to hold a stabilizing strap. The J pieces curve orifice to provide a vent for exhalation. back up over the nose to the forehead area where they connect to A corrugated tube connects the Y piece to the flow a Y piece. generator. Prescribed positive pressure is produced and regulated by the flow generator. Gas flow travels from the flow generator through a 22mm I.D. corrugated tube that connects to the Nasalflair wye piece which splits the flow and sends it through two flexible lSmm I.D tubes, each connects to a J shaped piece having cuffed cannulae that fit into patient's nares directing the air flow into the nasal passage, oral pharynx, trachea, and into the lungs . The Y piece is attached to a soft nylon lined foam pad that rests on the patient's forehead and is held in place with adjustable hook/loop straps. Different types of head gear may be used depending on individual patient preference.
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