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510(k) Data Aggregation

    K Number
    K130481
    Device Name
    SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK
    Manufacturer
    Date Cleared
    2013-05-24

    (88 days)

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

    CIRCADIANCE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SleepWeaver Anew Full Face Soft Cloth PAP Mask is intended to provide an interface for Positive Airway Pressure (PAP) therapy. This mask is intended for single-patient reuse in the home and in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs (30 kg).
    Device Description
    The SleepWeaver Anew Full Face Soft Cloth PAP Mask consists of a cloth cushion, headgear, and a 90° elbow swivel connector with anti-asphyxia valve.
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    K Number
    K120757
    Device Name
    SLEEPWEAVER ELAN NASAL CPAP MASK
    Manufacturer
    Date Cleared
    2012-04-24

    (42 days)

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

    CIRCADIANCE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SleepWeaver élan Nasal CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy. The SleepWeaver élan Nasal CPAP Mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 Ibs (30 kg).
    Device Description
    The SleepWeaver élan Nasal CPAP Mask serves as a mechanism for reliably connecting a patient > 66 lbs (30 kg) diagnosed with sleep apnea to a source of continuous or bi-level positive air pressure needed to maintain an open airway. The nasal mask is placed over a patient's nose and held in place by use of an adjustable elastic headgear. A cloth cushion contacts the patient's face. The mask assembly has an L-shaped tubing swivel connector which is compatible with the industry standard 22 mm air tubing. Air is supplied to the mask by a CPAP device (which can be standard CPAP or a bi-level device). The patient inhales air from the mask and exhales into the mask where continuous airflow from the CPAP device purges the exhaled carbon dioxide from the mask exhalation holes. The SleepWeaver élan can be used in the home environment (single-patient, multi-use) or the institutional environment (multi-patient, multi-use). Cleaning instructions are provided for each environment. Home use calls for washing with warm water and a mild non-abrasive soap. The institutional environment calls for cleaning a validated cleaning agent and a high-level disinfecting agent/process. The mask features a cloth cushion made of polyester fabric with a polyester/lycra/nylon interface material. The mask exhalation feature is incorporated into the cloth cushion. Attached to the cushion is an L-shaped 22-mm tubing swivel connector that can rotate 360°. The tubing connector can be detached by unscrewing the nut off the threaded connector for ease of cleaning and cushion replacement. The cloth headgear is connected to the mask through slots in the cushion wings. The headgear is removable for ease of cleaning and replacement. The SleepWeaver élan Nasal CPAP Mask also offers two optional accessories, the Feather Weight tube and the tether strap. The Feather Weight tube is an 18" plastic home-use only extension tube to improve flexibility at the mask connection point. The tether strap, when used, keeps the tubing from resting on the patient's head while he/she sleeps.
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    K Number
    K092362
    Device Name
    SLEEPWEAVER NASAL CPAP MASK
    Manufacturer
    Date Cleared
    2009-11-02

    (90 days)

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

    CIRCADIANCE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SleepWeaver™ Nasal CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs/ 30 kg.
    Device Description
    The SleepWeaver™ Nasal CPAP Mask serve as a mechanism for reliably connecting an adult patient diagnosed with sleep apnea to a source of continuous or bilevel positive air pressure needed to maintain an open airway. The nasal masks are fastened over a patient's nose by use of an 'elastic strap around the head. A cloth cushion contacts the patient's face. The mask assembly has a tubing connection which is compatible with the industry standard 22mm air tubing. Air is supplied to the mask by a CPAP device (the CPAP device can be a standard CPAP or Bi-Level type device). The patient inhales air from the mask and exhales into the mask where continuous airflow from the CPAP device purges the exhaled carbon dioxide from the mask through the mask exhaust vents. The mask is made entirely of cloth which provides a comfortable, secure and leakfree interface with the patient. The positive pressure within the system keeps the cloth mask open during use, while providing a leak-free interface to the patient's face. The mask has no structure, and without air pressure it is floppy. But once the CPAP pressure is applied, the mask inflates like a balloon. The air pressure inside the mask pushes the cloth surface against the patient's face. The mask takes on the contour of the patient's facial structure. Since the mask acts like a balloon, and all points in a balloon have the same pressure, the mask makes a leak-free seal with no pressure points. The SleepWeaver Soft Cloth CPAP Mask is made entirely of cloth. The cloth is 100% polvester that is used to produce clothing. The mask features a series of pin holes that serve as an exhalation vent.
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