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510(k) Data Aggregation

    K Number
    K134023
    Device Name
    2300 SERIES MGO PORTABLE OXYGEN
    Date Cleared
    2014-04-25

    (116 days)

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

    **ULTRA ELECTRONICS LIMITED PRECISION AIR **& LAND SY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 2300 Series mGO Portable Oxygen Generalor is 1-3 1./min continuous flow (1-6 1./min Pulse Flow), pressure vacuum swing adsorption, supplemental oxygen concentrator, based in molecular sieve technology. The patient the oxygen through a nasal cannula. The device is not intended for life support, nor does it provide any patient monitoring capabilities. The device is intended for use in environments found in medical facilities, military deployment situations or disaster areas for humanitarian relief. A Physician has prescribed a specific oxygen flow setting to meet an individual's needs. Oxygen flow serings should be adjusted only under the direction of a Physician. WARNING: Federal Law restricts this device to sale by or on order of a Physician
    Device Description
    The 2300 Series mGO Portable Oxygen Generator delivers supplementary oxygen to casualties and patients at the point of need, eliminating the need for oxygen cylinders. It is designed to function in harsh environments for military users and agencies engaged in humanitarian and relief operations. The 2300 Series mGO administers supplemental oxygen at a concentration of 93% ± 3% to USP32. The 2300 Series mGO can deliver oxygen at flow rates between 1 and 3 litres per minute (L/min), continuous flow, or, in pulse dose mode, an oxygen bolus of up to 84 millilitres (ml) (14 ml multiplied by the setting value, maximum of 6) equivalent to a continuous flow of 6 L/min in response to breath demand. This is termed Pulse Oximetry. The 2300 Series mGO is based on the pressure swing adsorption (PSA) principle. The 2300 Series mGQ delivers supplemental oxygen for patients through molecular sieve beds and is designed to conserve the use of oxygen in pulse dose mode. In pulse dose mode, oxygen is delivered to the patient through a pulse dose valve when a patient starts to inhale. Ambient air is drawn into the generator via a piston style compressor. The air first passes through a series of filters that remove dust, and other particulate matter before entering the compressor. A poppet-style solenoid valve directs air into one of two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases, while oxygen flows out of the sieve bed, thereby producing a highly enriched oxygen product. Simultaneously, in the second sieve bed, nitrogen is desorbed as the pressure decreases to a vacuum and is exhausted into the atmosphere. The cycle continues by alternately swapping the absorption/desorption process from one sieve bed to the other, providing a flow of oxygen to a receiver and the patient through a bacteria filter. The 2300 Series mGO consists of pneumatic and electrical components, a pressure and vacuum compressor, a pressure vessel, Synthetic Zeolite molecular sieve beds, two lithium ion batteries, dust separator and particulate inlet filter, valve assemblies, an outlet bacteria filter, electronic flow control, touch control pad, a cooling fan assembly, and audible/visual alarms. The 2300 Series mGO operates from 100-240 Volts AC mains power, 24-28 Volts DC power or two removable rechargeable batteries. The 2300 Series mGO may be carried manually (weight <10Kg) and transported by military or civilian vehicles on land, air and sea. The device is provided with a 4.76 mm hose tail that is used to attach a cannula tube.
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