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510(k) Data Aggregation

    K Number
    K143177
    Device Name
    KleenGel Dispenser
    Manufacturer
    KleenGel, LLC
    Date Cleared
    2015-09-14

    (314 days)

    Product Code
    KYX, KMJ
    Regulation Number
    880.6430
    Why did this record match?
    Product Code :

    KYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KleenGel hands-free dispenser is used to dispense lubricating gel for use by healthcare providers when performing pelvic and rectal exams and other procedures requiring lubricating gel.
    Device Description
    The KleenGel Dispenser is a patented automatic dispenser designed to efficiently and hygienically dispense lubricating gel for use by health care providers when performing pelvic and rectal exams or other procedures requiring the use of lubricating gel. The KleenGel Dispenser has an Infrared Sensor for automatic dispensing of lubricating gel onto the providers fingers or on a medical instrument. The unit is designed to be placed on a counter top so it's easily accessible to healthcare providers in exam rooms. The device is battery operated, using four (4) AA (1.5V) batteries. Device also has an optional AC adapter. Sterile Lubricating Gel, (sold separately) is packaged in a 14 oz pre-filled disposable cartridge. Gel is dispensed in 3 volume selections, 1ml, 2ml or 3ml.
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    K Number
    K980109
    Device Name
    CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER
    Manufacturer
    SANGSTAT MEDICAL CORP.
    Date Cleared
    1998-08-18

    (218 days)

    Product Code
    KYX
    Regulation Number
    880.6430
    Why did this record match?
    Product Code :

    KYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CycloTech™ Cyclosporine Oral Solution Dispenser (Dispenser) is intended to dispense SangCya™ cyclosporine oral solution USP (for microdispersion) as well as display and store dose size, time to next dose, remaining available doses, and doses dispensed.
    Device Description
    CycloTech™ is designed for use with a standard fifty (50) mL bottle. A disposable fluid path, fully enclosed by the outer plastic shell, has a 0.1 to 5.0 mL dose range with 0.1 mL per step resolution and an accuracy of plus or minus five percent (+ 5%) for dispensed volumes. This device has two (2) user buttons, a custom LCD display, one (1) year memory at two (2) doses per day (uploadable to a PC), six (6) months battery life using common AA-type alkaline batteries, and pump technology for a specified volume range. Use of a pump mechanism and microcomputer allows control of fluid delivery. The primary system upon which this product is based is the gravimetric principle of fluid delivery. The pump mechanism is used to assist the microcomputer in measuring amounts of liquid cyclosporine as well as dispensing the medication. The microcomputer, taking into account fluid viscosity, is able to provide an accurate, reproducible amount of liquid medication. CycloTech™ is comprised of a molded plastic case assembly with an interchangeable disposable fluid path assembly. The fluid path assembly will only accept the original container of cyclosporine oral solution obtained from the drug manufacturer (reservoir or medication supply bottle). The case assembly provides for setting or adjusting the amount of liquid delivered, for measuring time, and for storing data. This apparatus also provides visual and audio output to the user, a control processor for monitoring and recording the time and number of dispensed doses of medication, a method for alerting a user of the time for taking their dose(s) of medicine, and monitoring the amount of medication remaining in the fluid path and reservoir. Audio alarms for alerting a user are also included in the Dispenser. The control processor, via interface, may be linked with an external computer. A liquid dispensing valve assembly and pump are used for dispensing liquid medicines from the reservoir through the fluid path assembly.
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