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510(k) Data Aggregation

    K Number
    K024373
    Device Name
    MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
    Manufacturer
    ELLTEC CO., LTD.
    Date Cleared
    2003-01-28

    (28 days)

    Product Code
    LGZ, BSB
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELLTEC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The enteral nutrition warmer LIFORT LT-1 is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7ml/min. The LT-1 is available in two sizes: 4mm and 5mm channels for administration sets.
    Device Description
    The enteral nutrition warmer LIFORT LT-1 is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7ml/min. The LT-1 is available in two sizes: 4mm and 5mm channels for administration sets.
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    K Number
    K012906
    Device Name
    ANIMEC, MODELS AM-2S-4 AND AM-2S-5
    Manufacturer
    ELLTEC CO., LTD.
    Date Cleared
    2001-10-09

    (41 days)

    Product Code
    LGZ, BSB
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELLTEC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The infusion/blood warmer model ANIMEC AM-2S is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated in intravenous administration sets for intermittent use and low flow rate applications at 1 to 12ml/min. The AM-2S is available in two sizes: 4mm channel for I.V. administration sets and a 5mm channel for blood administration sets.
    Device Description
    The infusion/blood warmer model ANIMEC AM-2S is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated in intravenous administration sets for intermittent use and low flow rate applications at 1 to 12ml/min. The AM-2S is available in two sizes: 4mm channel for I.V. administration sets and a 5mm channel for blood administration sets.
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