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510(k) Data Aggregation

    K Number
    K964219
    Device Name
    ZIP CONDOM CATHETER
    Date Cleared
    1997-08-11

    (293 days)

    Product Code
    Regulation Number
    876.5250
    Why did this record match?
    Product Code :

    EYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1. For Penile Attachment Only 2. Non-indwelling Urinary Continence Aid 3. Management of Urinary Incontinence 4. Urine Collection Device
    Device Description
    The ZIP™ Condom Catheter has four basic elements: 1) the condom/sheath with integral urine collection compartment; 2) the Velcro-like band and support strap; 3) the Application ring; and 4) the specially designed male underpants brief. The condom/sheath with integral urine collection compartment forms a bulbous tube approximately 10 ½ inches long. The tube is divided into two sections, the condom/sheath and the urine collection compartment. Non-return flow valves separate the condom/sheath portion from the urine collection compartment. The distal end of the urine collection compartment is affixed with a twist-open twistclosed stop-cock drain valve. The urine collection capacity is approximately 450 ml. Typical human urine output thus yields a time related capacity of about 4 to 6 hours. A series of 4 sizes differing in sheath diameter and length will be offered. Specific name designators for the sizes are vet to be determined. Design: The ZIP™ Condom Catheter expands upon existing male urine continence devices by first approaching the device as a "total" or "system" concept rather than just a collection of items originally developed for other urine collection purposes. Only the essential elements of the ideal male urine continence system were considered. First, the system had to be easy to apply and use. Second, it should allow use of traditional male urination methods, i.e., the stand-up urinals found in public restrooms. Third, the system should be small enough to go unnoticed during the typical activities of daily living. Fourth, the system should have adequate capacity so that urine disposal intervals are not unreasonably short. Lastly, the system should be reusable and easily cleaned and sanitized. This is a natural latex containing product. The ZIP™ Condom Catheter is made from the exact same natural latex formulation as the Everyday - Self-Adhesive Urinary External Catheter made by Hollister. Inc. The use of pure latex to construct the ZIP™ Condom Catheter requires the inclusion of certain FDA required cautionary statements. Latex containing devices must legibly bear an appropriate allergic reaction statement on the device labeling. In conformance with this FDA requirement, Goulter Medical, Inc. attaches a label containing the following cautionary statement to the device. "This product is made from natural rubber latex which may cause allergic reactions in some individuals".
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    K Number
    K961906
    Device Name
    UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018
    Date Cleared
    1996-11-19

    (187 days)

    Product Code
    Regulation Number
    876.5250
    Why did this record match?
    Product Code :

    EYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UNI-GARD QUIK CATH™ is indicated for use to drain urine from the bladder and collect the urine from the bladder in a bag. uthe UNI-GARD QUIK CATH™ is a unisex intermittent unitized catheter system.
    Device Description
    The UNI-GARD QUIK CATH™ is a sterile, disposable device composed a introducer with lubricant, drainage catheter and urine of collection bag. The introducer containing the lubricant is pressed into the urethral meates until it stops. The catheter is advanced through the introducer and reservoir of lubricant while perforating the introducer tip to enter the urethra. The catheter is advanced until it reaches the bladder and urine begins to flow through the catheter into the urinary collection baq.
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