b2891e4f-5d4d-4b46-9462-a781b7648969UpdatePublished32025-05-202022-02-11In Commercial Distribution18800109201631PackageGS10880010920163410In Commercial Distribution08800109201634PrimaryGS128800109201638PackageGS118800109201631100In Commercial Distribution3Way Foley Balloon CatheterAPO-FC-324694741911AP MDS Co., Ltd.1This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a Manifold part and a Shaft parts. The Manifold Parts is equipped with a non-return valve for inflate the balloon and a band to fix the non-return valve and to identify the catheter’s size by color. The Shaft parts has an x-ray opaque line for check to position and balloon for located the catheter in the bladder, a drainage eye for urine drainage, and a rounded tip for easy insertion of the shaft. The proposed device is supplied in French size ranging from 12 to 24. It is available in 337(±15) and 345(±15) mm length with various balloon sizes. The devices are applied for adults only.falsefalsefalsefalsefalsetruetruetruetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationfalsetrue9252623218kcheungmd@gmail.comK20177600034917Indwelling urethral drainage balloon catheter, non-antimicrobialA flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.falseActiveEZLCatheter, Retention Type, BalloonHandling Environment TemperatureHandling Environment HumidityStorage Environment TemperatureStorage Environment Humiditytruefalse