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510(k) Data Aggregation

    K Number
    K070577
    Device Name
    ON THE GO SHARPS
    Manufacturer
    Date Cleared
    2007-07-13

    (135 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDPORT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The On the Go Sharps Transport & Disposal is intended as a single use, needle protection device. The device is intended to hold only one contaminated sharp. The device is designed for use with Insulin syringes. It is intended to be sold Over-the-Counter for personal use only; not for professional use or use in professional healthcare facilities.
    Device Description
    On the Go Sharps Container is designed as a single use device that holds a single contaminated sharp. The contaminated sharp is placed into the container and immediately locked using the Safe-Lock Lid. Once closed the device can not be opened thereby minimizing the risk of contamination.
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    K Number
    K023538
    Device Name
    TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER
    Manufacturer
    Date Cleared
    2002-11-01

    (11 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDPORT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Timex AccuCurve ™ Talking 30 Second Thermometer is an electronic thermometer to measure patient body temperature orally. Timex AccuCurve ™ Talking 30 Second Thermometer is intended for professional and over-the-counter use.
    Device Description
    Electronic Thermometer
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    K Number
    K023069
    Device Name
    TIMEX DIGITAL ORAL THERMOMETERS; TIMEX ACCUCURVE ORAL THERMOMETER
    Manufacturer
    Date Cleared
    2002-10-18

    (32 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDPORT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Timex ACCU-CURVE and Traditional Digital Oral Thermometers are electronic thermometers to measure patient temperature orally. Targeted users include professional and over-the-counter users.
    Device Description
    Timex ACCU-CURVE Digital Oral Thermometer, Timex Oral Digital Thermometer
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