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510(k) Data Aggregation

    K Number
    K111191
    Device Name
    AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
    Date Cleared
    2011-07-28

    (91 days)

    Product Code
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    WET NOSE TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Wet Nose Technologies (WNT) Audible Pressure Release Valve (APRV) is intended for use with 'positive pressure' breathing gas delivery systems (e.g., High Flow nasal Cannula or bubble CPAP type systems) for pediatric/infants patients utilizing continuous flow systems with flow rates greater than 0 L/min and up, and including 15 L/min. The device is intended for use when a disposable, low pressure (10 cm H2O +/- 2 cm H2O), low-moderate pressure (20 cm H2O +/- 4 cm H2O) or a moderate/high pressure (40 cm H2O +/- 8 cm H2O), audible, non-adjustable pressure relief valve is needed to be placed upstream of the patient in-line with the circuit to protect the patient from excessive inspiratory pressure in event of a downstream occlusion or an increase of system pressure above the relief pressure. Intended to alert the healthcare provider(s) of a need to take corrective action to reduce system pressure, the device emits an audible sound when circuit pressure is above relief pressure.
    Device Description
    The Audible Pressure Release Valve (APRV) is a custom valve designed specifically for pediatric/infant use within a Continuous Positive Airway Pressure (CPAP), High/Heated Flow Nasal Cannual (HFNC) and other pressure systems. This valve is a safety feature designed to limit the system pressure of the circuit to pressures below the APRV relief pressure range. The device is intended for use with flow rates greater than 0 L/min up to, and including, 15 L/min. The device is placed upstream of the patient in-line with the circuit to protect the patient from excessive inspiratory pressure in event of a downstream occlusion or an increase of system pressure above the relief pressure. Thus, this device may be used to regulate the maximum pressure achievable within a pressure system. Opening the APRV will activate an audible sound to alert Healthcare professionals of over pressurization and the possible need to take corrective action. The activation pressure of 10 cm H2O +/- 2 cm H2O is based on a relief pressure at 8 L/min is 8 and is 12 cm H2O at 15 L/min. The 20 cm H2O +/- 4 cm H2O is based on a relief pressure at 8 L/min is 16 cm H2O and at 15 L/min the relief pressure is 24 cm H2O. The activation pressure of 40 cm H2O +/-8 cm H2O is based on a relief pressure at 8 L/min is 32 cm H2O and at 15 L/min the relief is 48 cm H2O. The valve instantaneously reacts to an occlusion and automatically reset upon release of the occlusion. The device is disposable, single-patient use and is prescription only. WNT has custom Adaptors (Humidifier Adaptor and Oxygen Nipple) to interface with the Audible Pressure Release Valve and the appropriate inspiratory tubing. The Audible Pressure Release Valve and the custom adapter (Humidifier Adapter and Oxygen Nipple) are sterilized by gamma irradiation and supplied sterile in a bag pouch. Twenty-five bag pouches are packaged in a dispenser box. Each bag pouch and dispenser box is labeled with the contents and appropriate information per the FDA's Quality System Regulation and Labeling requirements.
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    K Number
    K091538
    Device Name
    PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100
    Date Cleared
    2010-03-25

    (303 days)

    Product Code
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    WET NOSE TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Wet Nose Technologies (WNT) Pressure Release Valve is intended for use with 'positive pressure' breathing gas delivery systems (e.g., High Flow Nasal Cannula or Bubble CPAP type systems) for pediatric/infants patients utilizing continuous flow systems with flow rates greater than 0 L/min and up to, and including 15 L/min. The device is intended for use when a disposable, low pressure (20 cm H20 +/- 4 cm H2O activation), audible, non-adjustable pressure relief valve is needed to be placed upstream of the patient in-line with the circuit to protect the patient from excessive inspiratory pressure in event of a downstream occlusion or an increase of system pressure above the relief pressure. Intended to alert the healthcare provider(s) of a need to take corrective action to reduce system pressure, the device emits an audible sound when circuit pressure is above relief pressure.
    Device Description
    The Pressure Release Valve (PRV) is a custom valve designed specifically for pediatric/infant use within a Continuous Positive Airway Pressure (CPAP), High/Heated Flow Nasal Cannual (HFNC) and other pressure systems. This valve is a safety feature designed to limit the system pressure of the circuit to pressures below the PRV relief pressure range. The device is intended for use with flow rates greater than 0 L/min up to, and including, 15 L/min. The device is placed upstream of the patient in-line with the circuit to protect the patient from excessive inspiratory pressure in event of a downstream occlusion or an increase of system pressure above the relief pressure. Thus, this device may be used to regulate the maximum pressure achievable within a pressure system. Opening the PRV will activate an audible sound to alert Healthcare professionals over pressurization and the possible need for corrective action. The activation pressure 20 cm H2O +/- 4 cm H2O is based on the relief pressure at 8 L/min is 16 is 20 cm H2O and at 15 L/min is 24 cm H2O. The valve reacts instantaneously to an occlusion and automatically resets upon release of the occlusion. The device is disposable, single-patient use and is prescription only. The Pressure Release Valve connects with the pressure tubing by way of a Wet Nose Technologies 'T6' Adapter. The Pressure Release Valve and the 'T6' Adapter are sterilized by gamma irradiation and supplied sterile in bag pouch. Fifty bag pouches are packaged in a dispenser box. Each bag pouch and dispenser box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
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