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510(k) Data Aggregation

    K Number
    K120920
    Device Name
    HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA
    Manufacturer
    HSINER COMPANY
    Date Cleared
    2012-07-16

    (111 days)

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

    HSINER COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hsiner Pediatric CPAP Silicone Nasal Mask is intended to be use with patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician. The Hsiner Nasal Pillow Mask is intended to be use patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.
    Device Description
    Hsiner's Pediatric CPAP Silicone Nasal Mask and Hsiner's Nasal Pillow Mask are both product line extensions to their existing line of CPAP interface devices for the application of CPAP/VPAP therapy.
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    K Number
    K102120
    Device Name
    NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
    Manufacturer
    HSINER CO., LTD.
    Date Cleared
    2011-08-12

    (379 days)

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

    HSINER CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hsiner NIPPV masks provide a patient interface for application of noninvasive ventilation with ventilators with adequate alarms and safety systems to protect the patient in the event for ventilator failure. These masks are intended for use with spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure suitable for nominvasive pressure support ventilation treatment in the hospital/institutional environment (including but not limited to moderate.or severe dyspnea; elevated respiratory rates, labored breathing; or paradoxical breathing).
    Device Description
    Hsiner's NIPPV Masks are intended to provide a patient interface between a conventional mechanical ventilator system and the patient for applications of non-invasive ventilation. The comection to the ventilator utilizes standard 22mm conical connections complying with ISO 5356-1. The interface with the patient's facial contours utilizes a soft, pliable seal that ensures that a good seal is achieved to deliver the pressurized gasses with minimal unintentional leakage, Unintentional gas leak around the face is minimized by the mask base to improve the closeness of fit to the skin. Soft, clastic headgear insures a tight comfortable fit against the face. The Esiner NIPPY Masks are modifications to their CPAP/VPAP Masks (K063268). These masks differ from the CPAP/VPAP mask only in that the vents and anti-asphyxiation valves have been removed.
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    K Number
    K091185
    Device Name
    70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
    Manufacturer
    HSINER CO., LTD.
    Date Cleared
    2009-07-24

    (92 days)

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

    HSINER CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable single patient use bidirectional filters used to reduce the possible bacterial and/or viral cross contamination of ventilatory and anesthesia equipment associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. These devices are intended for use on all patient populations to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
    Device Description
    The BFE/VFE filters, manufactured by Hsiner, ITD are disposable, single-use barrier type, bi-directional devices supplied to the customer packaged and non-sterile. These filter devices are fabricated with a filtering medium that is highly effective at reducing the numbers of both bacterial and viral contaminates present in a patient's exhaled gas. The devices are designed to minimize the resistance to air flow. They consist of two molded plastic housings enclosing a disk of filter media. The Hsiner filtered HME device also includes a reticulated foam that captures heat and moisture from the patient's breath.
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    K Number
    K082009
    Device Name
    HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
    Manufacturer
    HSINER CO., LTD.
    Date Cleared
    2008-08-22

    (30 days)

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

    HSINER CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hsiner Nebulizer Bottle is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
    Device Description
    The Hsiner's nebulizers are used to administer various aerosol treatments in both the homecare and hospital settings. They are intended to only be use with FDA-approved drugs upon the specific direction of a physician. These devices neither uses specific drug nor is it distributed with such drugs. These nebulizers generate respirable sized aerosols that are delivered directly to the patient for breathing. The nebulizer operates on a compressed gas source which draws liquids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction ad baffling.
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    K Number
    K070948
    Device Name
    HSINER NEBULIZER BOTTLE
    Manufacturer
    HSINER
    Date Cleared
    2007-04-25

    (21 days)

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

    HSINER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hsiner Nebulizer Bottle is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
    Device Description
    The Hsiner Nebulizer Bottle is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used specific drug nor is it distributed with such drugs. The nebulizer sprays respiratory size aerosolized liquids into gasses that are delivered directly to the patient for breathing. The nebulizer operates on a compressed gas source which draws liguids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction and baffling.
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    K Number
    K063268
    Device Name
    CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
    Manufacturer
    HSINER CO., LTD.
    Date Cleared
    2007-02-23

    (116 days)

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

    HSINER CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hsiner CPAP/VPAP masks are intended to be use in a home, hospital or Institutional environments for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be use under the specific direction of a physician.
    Device Description
    The Hsiner CPAP/VPAP Masks is used to administer various aerosol treatments in both the homecare and hospital settings.
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    K Number
    K053466
    Device Name
    HSINER RESUSCITATOR
    Manufacturer
    HSINER CO., LTD.
    Date Cleared
    2006-03-22

    (99 days)

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

    HSINER CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hsiner PEEP Valve is used in conjunction with manual resuscitators and other ventilatory support equipment to provide positive end expiratory pressure.
    Device Description
    The PEEP valve is an adjustable, spring actuated valve which when placed into a circuit provides positive end expiratory pressure for the patient. The PEEP vale is provided in two pressure ranges and several connector sizes complying wit ISO 5356-1 "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets".
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    K Number
    K052811
    Device Name
    HSINER JET NEBULIZER, MODEL HS-31100
    Manufacturer
    HSINER CO., LTD.
    Date Cleared
    2005-12-21

    (78 days)

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

    HSINER CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hsiner Jet Nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
    Device Description
    The Hsiner Jet Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used specific drug nor is it distributed with such drugs. The nebulizer sprays respiratory size aerosolized liquids into gasses that are delivered directly to the patient. The nebulizer operates on a compressed gas source which draws liquids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction and baffling.
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