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510(k) Data Aggregation

    K Number
    K013133
    Device Name
    NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
    Manufacturer
    NORDIX, INC.
    Date Cleared
    2001-11-13

    (55 days)

    Product Code
    MOQ, MOZ
    Regulation Number
    878.4820
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORDIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement Battery for Baxter Flo-Gard Pump 8000, 8100, 8200 Infusion Pumps inidator. Formps This battery is sold only to customers who request a replacement battery for a particular device or to replace a competitor's Dattery for a particular dovice of to a loss equipment technician knows the intended use is as a replacement battery.
    Device Description
    Nordix Rechargeable Battery Part Number 2116
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