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510(k) Data Aggregation

    K Number
    K062444
    Device Name
    HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT
    Manufacturer
    OASIS MEDIKAL URUNLER KIMYA SANAYI VE TIC A.S.
    Date Cleared
    2007-02-22

    (185 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    OASIS MEDIKAL URUNLER KIMYA SANAYI VE TIC A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hi-Slip, Hi-Slip Plus and Hi-Slip Kit are launched for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
    Device Description
    The Hi-Slip Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of sizes and lengths. The Hi-Slip Plus Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable PVC (medical grade) catheter coated with hydrophilic polymer and water sachet (sterile water). Coating is activated by the water of integrated water sachet. Water is let down by squeezing the water sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The PLUS is provided in a variety of sizes and lengths. Hi-Slip Kit includes a single use coated PVC (medical arade) catheter, urine bag (medical grade PVC urine bag), water sachet (sterile water) and povidone iodine swab for cleaning urethra outlet prior to catheterization. The catheter is coated with a hydrophilic polymer (polyvynil pyrolidone, PVP) which makes the catheter surface slipperv when dipped into the water. Patient clean the urethra outlet by using povidone iodine swab and lets the water fill the catheter place in the urine bag by squeezing the sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. Patient disposes the urine directly into urine bag. The KIT is provided in a variety of sizes and lenaths.
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