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510(k) Data Aggregation

    K Number
    K211056
    Device Name
    Oxus Sieve Beds
    Manufacturer
    Oxus, Inc.
    Date Cleared
    2023-05-31

    (782 days)

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

    Oxus, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Refurbished Replacement Column (Sieve Bed) are regular replacement parts for Inogen One G3 Oxygen Concentrator. The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.
    Device Description
    The subject device is a compatible replacement part of the Inogen One G3 portable oxygen concentrator. ("POC"). Standard portable oxygen concentrators generate oxygen from room air by use of a sieve bed that removes nitrogen, other gases and impurities from the room air and generates oxygen for patients requiring supplement oxygen. These sieve beds must be replaced on a schedule in order to maintain the POC's ability to deliver the require % oxygen. The subject device is refurbished with existing Inogen One G3 components with a new sieve bed. The final product is equivalent to the Inogen one G3 replacement sieve bed cartridge.
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    K Number
    K162433
    Device Name
    GCE Zen-O Portable Oxygen Concentrator
    Manufacturer
    OXUS, INC
    Date Cleared
    2017-05-24

    (266 days)

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

    OXUS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment.
    Device Description
    The GCE Zen-O™ (Model RS-00500) POC is the latest design of POC from Oxus, Inc. The GCE Zen-O™ POC delivers 87% - 96% oxygen to a patient through a standard singlelumen nasal cannula. The GCE Zen-O™ POC detects a patient breath and operates by delivering a bolus of oxygen during the inhalation period (pulse mode) or can provide a continuous flow of oxygen (continuous mode). The device is portable, enabling patients who need an oxygen device to be treated at home according to a clinician's prescription or direction. The GCE Zen-O™ POC can be set to deliver flowrates between 1-6 LPM in pulse mode and 0.5-2 LPM in continuous mode; both with increments of 0.5 LPM to a patient. The device can be operated when powered by the 100-240VAC AC/DC power supply provided with the unit and designed to operate with a DC automotive adaptor. In addition, the device contains a rechargeable battery allowing it to be carried by a patient while traveling.
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