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510(k) Data Aggregation

    K Number
    K100957
    Device Name
    DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION
    Date Cleared
    2011-01-21

    (289 days)

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

    PACIFIC CONSOLIDATED INDUSTRIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Deployable Oxygen Concentration System (DOCS) Family of devices generates and delivers USP grade 93% ± 3% oxygen. The oxygen supplied by these units is for supplemental not considered to be life supporting or life sustaining. DOCS Family devices may be used to fill high pressure oxygen cylinders for use in locations remote to the DOCS unit or for ambulatory patient use. These devices are to be used only by trained personnel in disaster relief, crisis response or humanitarian relief situations where bottled or bulk oxygen is not readily available, as hospital backup systems, in local emergencies where disaster has rendered the primary oxygen supply unusable, or by trained military personnel in peacetime or wartime support of Armed Forces.
    Device Description
    The Deployable Oxygen Concentration System (DOCS) is a family of electromechanical devices that use a molecular sieve to adsorb nitrogen, water and carbon dioxide from filtered air, producing an output of high purity oxygen (93 ± 3 %) via the Vacuum Swing Adsorption process. The remainder of the gas product consists mostly of argon and nitrogen. Depending on the unit size, the resulting high purity oxygen can be delivered at flow rates ranging from 66 to 500 liters per minute at a pressure of 50 - 100 psig under standard conditions. Selected models may be configured with one or two integral high pressure compressors or an accessory high pressure compressor may be added to some models. These high pressure units are capable of filling oxygen cylinders to 2,250 or 3,000 psig.
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    K Number
    K061414
    Device Name
    EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD
    Date Cleared
    2007-01-22

    (245 days)

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

    PACIFIC CONSOLIDATED INDUSTRIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Expeditionary Deployable Oxygen Concentration System (EDOCS-120B) is intended to generate and deliver USP grade 93% +/- 3% oxygen for supplemental oxygen use. This device is to be used only by trained personnel in disaster relief situations where bottled oxygen is not readily available. The Mobile Oxygen Storage Tank (MOST) is intended to store and dispense USP grade 93% (+7%/-3%) oxygen at 50psig nominal pressure for supplemental oxygen use. This device is to be used only by trained personnel in disaster relief situations where bottled oxygen is not readily available.
    Device Description
    The Expeditionary Deployable Oxygen Concentration System (EDOCS) is a family of devices that draw in normal air and produce oxygen. The EDOCS separates nitrogen from the air, producing an output of concentrated oxygen at 93 percent by the molecular sieve process. The final product contains not less than 90 percent and not more than 96 percent oxygen, by volume. The remainder of the product consists mostly of argon and nitrogen. EDOCS employs an integral oxygen analyzer to provide control of oxygen purity. The EDOCS device is an electromechanical device consisting primarily of a molecular sieve type oxygen concentrator, a compressor module(s), and one or more oxygen collection cylinders. The oxygen concentrator operates by adsorbing water and nitrogen from filtered air. Depending on the unit size, the resulting gas has increased oxygen at flow rates from 30 to 500 liters per minute at a pressure of 50 - 100 psi nominal and is capable of high pressure cylinder filling. The Mobile Oxygen Storage Tank (MOST) is a oxygen storage and distribution system consisting of lightweight, high-pressure, composite wound, brass lined cylinders and a distribution manifold secured within a rugged waterproof case. The MOST contains 10,000 liters of oxygen when filled to 2,250 psig (13,400 liters at 3,000 psig). The MOST has a maximum flow capability of 225 LPM, which is equivalent to 75 LPM per Oxygen Output fitting (3 fittings per MOST). These three oxygen output flows would typically be subdivided further by the customer's equipment.
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