Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K213210
    Device Name
    Oxygen Concentrator, Model JAY-5AW
    Date Cleared
    2022-12-08

    (435 days)

    Product Code
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONGFIAN SCITECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Longfian Oxygen Concentrator, Model JAY-5AW is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model JAY-5AW, can be used at home or healthcare environments. The Longfian Oxygen Concentrator, Model JAY-5AW, does not nor is it intended to sustain or support life. The device is intended for use in adults.
    Device Description
    The Longfian Oxygen Concentrator, Model JAY-5AW adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method. The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The weight of Jay-5AW is around 16kg (~351bs). There is no influence on indoor oxygen percent during the generator operating. The biocompatibility contact classification of the device is as permanent contact externally communicating with dry and humified gas pathway. The life-time/use life of the oxygen concentrator is set at 5 years or 20.000 hours after the product is sold, whichever comes first. The reusable components: - Intake air filter (two pieces, part number:GL-01) - Secondary filter (one piece, part number:GL-02) - nasal oxygen tube and - humidifier. JAY-5AW medical oxygen concentrator contains the following items: - One (1) JAY-5AW Oxygen Concentrator Unit - One (1) AC Power Supply - One (1) Nasal Oxygen Tube - One (1) Firesafe Cannula Valve - One (1) Humidifier - One (1) Operation Manual
    Ask a Question

    Ask a specific question about this device

    K Number
    K131968
    Device Name
    LONGFIAN OXYGEN CONCENTRATOR
    Date Cleared
    2014-09-05

    (434 days)

    Product Code
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONGFIAN SCITECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Longfian Oxygen Concentrator, Model Jay-5 is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model Jay-5 can be used in a home, institution, vehicle, and various mobile environments. The Longfian Oxygen Concentrator, Model Jay-5 does not nor is it intended to sustain or support life.
    Device Description
    JAY-5 medical oxygen concentrator adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method. The concentrator can supply 1-2 patients simultaneously, with steady oxygen flowing out and reliable, adjustable flow. The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The key parts of the generator adopt anti-tiring and anti-aging design, and the planned life of the whole generator reaches up to 20,000 hours. The weight of Jay-5 is around 25kg (~55lbs). There is no influence on indoor oxygen percent during the generator operating. JAY-5 medical oxygen concentrator contains the following items: - · One (1) Jay-5 Oxygen Concentrator Unit - · One (1) AC Power Supply - · One (1) Nasal Oxygen Tube - One (1) Humidifier - One (1) Operation Manual
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1