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510(k) Data Aggregation

    K Number
    K062644
    Device Name
    FLEXWARMER, MODELS KZ-1 AND KZ-2
    Manufacturer
    MERLYN ASSOCIATES, INC.
    Date Cleared
    2007-09-11

    (370 days)

    Product Code
    LGZ,IME
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The portable infusion warmer, FLEXWARMER KZ-1 and KZ-2 is dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate application at 1 to 8 mL/min.

    The KZ-1 and KZ-2 is available in two sizes: 4mm and 5mm channels for administration sels.

    Device Description

    The portable infusion warmer, FLEXWARMER KZ-1 and KZ-2 is dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate application at 1 to 8 mL/min.

    The KZ-1 and KZ-2 is available in two sizes: 4mm and 5mm channels for administration sels.

    AI/ML Overview

    This document is a 510(k) clearance letter for an infusion warmer (FlexWarmer KZ-1 and KZ-2). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to software or AI performance. The device is an infusion pump, which is a physical medical device, and the information provided here is a regulatory clearance, not a technical performance report.

    Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text.

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