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510(k) Data Aggregation

    K Number
    K240561
    Device Name
    Rugged Oxygen Generator (ROG) (RO01-00001)
    Manufacturer
    Molecular Products Ltd.
    Date Cleared
    2024-12-06

    (281 days)

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

    Molecular Products Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to produce oxygen for emergency use at 6 LPM flow rate for at least 15 minutes (90 liters) for individuals 17 years and older requiring emergency or supplemental oxygen.
    Device Description
    The Rugged Oxygen Generator (ROG) is intended for environment such as emergency use, home use, and commercial use and is OTC. The ROG is designed to provide supplemental oxygen and is a single use product. The ROG is a chemical oxygen generator that produces a minimum of 90 liters of oxygen at ≥96% purity for minimum of 15 minutes with an average flow rate of 6 liters per minute or greater. There is a need for oxygen in a variety of applications/locations where compressed oxygen cylinders are not suitable. Principle of Operation: The subject device is initiated though a friction interaction between an integrated phosphorous match and the candle block. To initiate, open the lid and turn the dial clockwise 2-3 times. The turning of the dial will rotate the match and screw the match down into the candle block. This will start the chemical reaction, which will produce oxygen. Once oxygen is flowing, close the lid and place the face mask onto patient.
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    K Number
    K131016
    Device Name
    ROGS
    Manufacturer
    MOLECULAR PRODUCTS LTD.
    Date Cleared
    2013-11-27

    (230 days)

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

    MOLECULAR PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to produce oxygen for emergency use at 6 lpm flow rate for at least 15 minutes (90 liters).
    Device Description
    The ROGS is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.
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    K Number
    K062153
    Device Name
    PORTABLE OXYGEN GENERATOR SYSTEM
    Manufacturer
    MOLECULAR PRODUCTS LTD.
    Date Cleared
    2006-11-21

    (117 days)

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

    MOLECULAR PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable Oxygen Generator (POG) is intended to produce oxygen for emergency use at 6 lpm for at least 15 minutes.
    Device Description
    The Molecular Products' POG is a chemical based portable oxygen generator which generates 99% oxygen for 15 minutes at a flow rate of 6 lpm. It is a self-contained device with the oxygen delivered via a standard oxygen face mask or nasal cannula.
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