Search Filters

Search Results

Found 10 results

510(k) Data Aggregation

    K Number
    K110518
    Device Name
    IBAG
    Manufacturer
    FUTURE PATH MEDICAL, LLC
    Date Cleared
    2011-06-24

    (121 days)

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

    KNX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to measure/ display collected urine volume. It detects fill level and temperature.
    Device Description
    iBag™ is a urine management system that includes bladder and temperature measurement for catheterized patients who desire to be fully mobile. · iBag™ provides accurate, real-time assistive data. It does this through use of a calibrated drainage bag integrated with a Future Path Medical sensor, a base transmitter unit called Wi-Mitter™ for wireless transmission of urine bag fill and bladder temperature information. Once the Wi-Mitter™ is snapped in place, the container is polled and the measurement of fluid level begins and this data is then transmitted to the patient, the care provider (an aid) a family member, or even to the hospital's base station. Data is transmitted via traditional data networking and may be interpreted and displayed on a user's laptop computer, and other types monitors. Since the data from the Wi-Mitter™ is time and date stamped, time of fill level may be automatically calculated, noted and threshold values used for fill level alarming.
    Ask a Question
    K Number
    K973364
    Device Name
    4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
    Manufacturer
    MAERSK MEDICAL A/S
    Date Cleared
    1998-03-17

    (190 days)

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

    KNX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The basics of the intended use has not changed. The Maersk Medical 4L drainage bag continue to be intended for collection of fluid which is on its way away from the body. The 4L drainage bag can be used in different treatment procedures within areas as urology and dialysis, but in any case the intended use is the same. The device label will state the following: A: "Peritoned Dialysis Drainage bag" B: "Collection bag fer urine"
    Device Description
    The general description, operation, construction and use of the Maersk Medical 4L drainage bag has not changed as a result of the modifications. The 4L drainage bag contains basically the same features as the device described in K843480 and the manufacturing process is identical. However the 4L drainage bags will hold 4000 ml. compared to 2000 ml. for the device described in K843480. On a few points features has been added to the 4L drainage bag, but they are all added to improve patient and healthcare personnel comfort.
    Ask a Question
    K Number
    K972887
    Device Name
    MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    1997-12-11

    (128 days)

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

    KNX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are indicated for use by incontinent persons with other medical conditions that warrant the use of a leg bag and are intended to collect urine. They may be connected to either an indwelling or non-indwelling catheter.
    Device Description
    Medline Leo Bags are vinyl pouches with sterile fluid paths and adjustable comfort straps. This device is attached to the leg of an incontinent person and used to collect urine. This device may be used with an indwelling catheter or an external catheter. A leg bag provides the catheterized person with greater mobility and are usually worn during the day and are replaced at night with a standard urinary drainage bag.
    Ask a Question
    K Number
    K971271
    Device Name
    BESECURE EXTERNAL URINARY COLLECTION SYSTEM
    Manufacturer
    UROLOGY RESEARCH INTL., INC.
    Date Cleared
    1997-08-18

    (136 days)

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

    KNX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BeSECURE External Urinary Collection System is an external urine collection system for the incontinent patient.
    Device Description
    Not Found
    Ask a Question
    K Number
    K971929
    Device Name
    AMSINO URINARY LEG BAG
    Manufacturer
    AMSINO INTL., INC.
    Date Cleared
    1997-08-06

    (71 days)

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

    KNX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Amsino Urinary Leg Bag is a device intended to collect urine.
    Device Description
    Not Found
    Ask a Question
    K Number
    K971764
    Device Name
    WELCON HUE-VU URINARY DRAINAGE BAG
    Manufacturer
    WELCON, INC.
    Date Cleared
    1997-07-29

    (77 days)

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

    KNX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Welcon Hue-Vu™ Urinary drainage Bag is indicated for use for the collection of urine when used with an indwelling catheter.
    Device Description
    The Welcon Hue-Vu™ Urinary Drainage Bag is a 2000 ml capacity vented vinyl urine collection receptacle intended to be used with an indwelling catheter. The bag has a hanging hook at the top, and is equipped with a sampling port near the catheter connector. The inlet tubing has an anti-reflux valve to prevent backflow. A vent allows air to escape the bag as urine enters. A Hue-Vu™ color strip label is affixed to the front of the bag, and is used to compare and record the color of the urine collected in the bag.
    Ask a Question
    K Number
    K964690
    Device Name
    LIBERTY VALVE
    Manufacturer
    CLEVELAND MEDICAL DEVICES, INC.
    Date Cleared
    1997-03-21

    (119 days)

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

    KNX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Liberty Valve is intended to allow individuals in a wheelchair to empty their own urine collection leg bag, which may be connected to either an indwelling or non-indwelling catheter, provided the individual possesses the ability to make gross arm and hand movements.
    Device Description
    The Liberty Valve consists of a switch box, a solenoid valve with electrical connection, a fuse, battery leads with wiring, and tubing with the necessary connections for attachment to the leg bag and valve. The device is to be mounted to the wheelchair permanently with the clamps and wire ties provided. The switch box regulates the power from the battery which opens the solenoid valve the urine collection leg bag to drain.
    Ask a Question
    K Number
    K964745
    Device Name
    AMSINO URINARY DRAINAGE BAG
    Manufacturer
    AMSINO INTL., INC.
    Date Cleared
    1997-03-18

    (112 days)

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

    KNX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962652
    Device Name
    URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
    Manufacturer
    CUSTOMED, INC.
    Date Cleared
    1996-10-04

    (88 days)

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

    KNX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960949
    Device Name
    PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167
    Manufacturer
    BRISTOL-MYERS SQUIBB
    Date Cleared
    1996-04-19

    (39 days)

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

    KNX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    indicated for use in the collection of free flowing urinary drainage.
    Device Description
    ProSys™ Bedside Drainage Bag (Sterile) is available with a 2000 ml volume capacity. Each stèrile bag is fitted with a permanently welded 55 inch inlet tube containing a universal connector which connects to an indwelling or external catheter. The Bedside Drainage Bag (Sterile) has a T-tap drainage valve. The inlet tube contains an anti-reflux valve to reduce the risk of urine backflow and infection and, a sample port used for urine sampling is integrated into the universal connecter.
    Ask a Question

    Page 1 of 1