Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K132778
    Device Name
    GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
    Manufacturer
    PRAXAIR HEALTHCARE SERVICES
    Date Cleared
    2014-07-07

    (305 days)

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

    PRAXAIR HEALTHCARE SERVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Grab 'n Go system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is MR Conditional, and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. The device is intended for limited duration use, such as would be necessary during patient transports.
    Device Description
    The Grab 'n Go Plus / Grab 'n Go Digital (collectively referred to as the Grab 'n Go system) integrated delivery system supplies oxygen using a device comprising an integrated valve-regulator with pressure gauge, flow meter and oxygen gas cylinder with protective shroud all integrated into a single unit. The device is able to provide a range of user selectable flow settings, including low and high flows that may be clinically appropriate for certain classes of patients. An additional DISS connection provides standard 50-PSI oxygen gas delivery. The optional digital pressure gauge (Grab 'n Go Digital) provides both audible and visual low contents alerts and alarms as well as estimated time of use. The system must only be used by trained medical personnel.
    Ask a Question

    Page 1 of 1