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510(k) Data Aggregation

    K Number
    K222279
    Device Name
    Rusch Intermittent Urethral Catheters
    Manufacturer
    Teleflex Medical
    Date Cleared
    2022-08-29

    (31 days)

    Product Code
    EZC
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    EZC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
    Device Description
    The Intermittent Urethral Catheters consist of a tubular shaft with attached funnel as the connecting device. PVC material used in the catheter. The product sizes range from 10 Ch. to 24 Ch. The device shaft is uncoated.
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    K Number
    K173596
    Device Name
    Rusch Intermittent Urethral Catheters
    Manufacturer
    Teleflex Medical
    Date Cleared
    2018-01-29

    (69 days)

    Product Code
    EZC, EZD
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    EZC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intermittent Urethral Catheters are indicated for routine drainage of fluids from the bladder. These catheters are not intended or designed for indwelling use.
    Device Description
    The Rusch® Intermittent Urethral Catheters are single use, uncoated, disposable and sterile. The catheter is comprised of a tip, shaft, and funnel. The catheter tube is made of polovviny chiloride (PVC), the tip of a PVC/liquid colored PVC which is cured to the tube and a catheter funnel also made of PVC. The dimensions range from Charrièr (Ch.) Ch. 10 to Ch. 24 which is a range of 3.3 mm to 7.9 mm in Outer Diameter with a length 40 cm. The catheters are produced with two different tips - Tiemann and Nelaton-Robinson. Each catheter size has a color-coded tip. The Nelaton-Robinson catheters have a size range from 10 Ch. to 24 Ch. and have two drainage holes. The Tiemann catheters have a size range from 12 Ch. and also have two drainage holes. Additionally the Tiemann and Nelaton-Robinson catheters also contain funnel adhesive solution to which the funnel is adhered to the shaft and hot embossing film or tint for printing text on the catheter.
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