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510(k) Data Aggregation

    K Number
    K042609
    Device Name
    HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
    Manufacturer
    HOSPIRA, INC.
    Date Cleared
    2004-10-06

    (12 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K042081,K030459,K011975
    Why did this record match?
    Reference Devices :

    K042081, K030459, K011975

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Hospira MedNet™ Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters.

    The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician's orders.

    Device Description

    The Hospira MedNet™ Medication Management Suite is an optional software product intended for use in healthcare facilities by trained healthcare professionals to facilitate networked communications (wired or wireless) between MMS compatible hospital information systems and Hospira infusion pumps, such as the Plum A+ 9. The feature of pre-populating infusion parameters is being added to reduce the number of manual steps to program an external infusion pump.

    The MMS provides healthcare professionals with the capability to send, receive, and store information from infusion pumps. The bi-directional communication includes infusion parameters, pump default configurations, pump location, history, events, trending, alarms and status. The MMS cannot remotely start, modify, or terminate ongoing infusions.

    AI/ML Overview

    The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a 510(k) summary for the Hospira MedNet™ Medication Management Suite. It primarily focuses on demonstrating substantial equivalence to predicate devices, describing the device's intended use and technological characteristics. It does not detail specific performance metrics, clinical studies, or the methodologies typically associated with proving a device meets predefined acceptance criteria.

    Therefore, I cannot provide the requested information based on the input text.

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