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510(k) Data Aggregation

    K Number
    K993125
    Device Name
    SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM
    Date Cleared
    2000-06-20

    (274 days)

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

    SAFETY MEDICAL SUPPLY INT,., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SafetyTip™ Multi-Sample Needle and SafetyTing Blood Collection The Sarely In -- Mun-Sample thood collection. The safety sheath helps to System is to be used for vehous blood conceasing the needle before and after use.
    Device Description
    The Multi-Sample needle consists of a Cannula, Hub, Safety Sheath, Rubber Sleeve, and lower cover. The Multi-Sample needle consists of a hypodermic needle in sizes 18 Gauge to 22 gauge with lengths of 1" to 3 ½". It has a hinged cover/sheath that is pulled open by the user by pinching the sides to expose the needle. When closing there are two levels, first. Close the sheath over the needle by pressing the needle down against any hard surface. At this noint the needle may be re-opened by using the normal technique. To use the permanent locking system, close the sheath over the needle by pressing the needle down against any hard surface then, pressing the tip of the sheath with more force until the needle is lodged between the locking tabs, creating a permare rot lock. The SafetyTip™ Blood Collection System consists of a Cannula, Hub, Safety Sheath, Medical Surgical Grade Rubber Sleeve Holder and The Tube Holder. This is a "safety" device in that by using the permanent-locking feature, It may prevent accidental needlesticks. Its one-handed loosing motion is in compliance with the CAL-OSHA standards. When cloning the Safety Tip™ Blood Collection System there are two levels, first. close the sheath over the needle by pressing the needle down against any hard surface. At this point the needle may be re-opened by using the normal technique. To use the permanent locking system, close the sheath over the needle by pressing the needle down against any hard surface then, pressing the tip of the sheath with more force until the needle is lodged between the locking tabs, creating a permanent lock.
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