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510(k) Data Aggregation

    K Number
    K080695
    Device Name
    MOBILE I.V. SYSTEMS 10,20,60
    Date Cleared
    2008-07-01

    (112 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTHWIND TECHNOLOGIES, CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indicated as a single use, sterile device for use in gravity fed I.V. therapy or with a pressure infuser, when an extended fluid path is required for administration. Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration.
    Device Description
    Mobile I.V. Systems device, the Primary I.V. Fluid Administration Set consists of a tubing set with either a 0.2 um or a 1.2um GVS S.p.A filter, universal spike, all position drip chamber, two injection sites and a removable Easydrop flow regulator and is used as a fluid pathway for I.V. administration. Mobile I.V. will offer three models, which will allow the choice of 10drops/ml, 20 drops/ml, or 60 drops/ml. The Primary I.V. Fluid Administration Set was designed for Emergency Medical and Hospital settings and includes an all position drip chamber. The drip chamber allows the flow of liguid regardless of the position of the drip chamber.
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