LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K153518
    Device Name
    Medipure Oxygen-LC System
    Manufacturer
    PRAXAIR DISTRIBUTION, INCORPORATED.
    Date Cleared
    2016-06-03

    (178 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRAXAIR DISTRIBUTION, INCORPORATED.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medipure Oxygen-LC System is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is intended for limited duration use, such as would be necessary during patient transport.
    Device Description
    The Medipure Oxygen-LC System is an integrated medical gas delivery system. The Medipure Oxygen-LC System is comprised of the Cavagna MVA2 series oxygen Valve Integrated Pressure Regulator (VIPR) permanently mounted to a large steel cylinder, either K or T size, and protected by a plastic guard. The Medipure Oxygen-LC System is a result of a design modification to the previously cleared Praxair Grab 'n Go Plus System (K132778).
    Ask a Question

    Page 1 of 1