d0d8249f-1836-46aa-a797-152b61853863UpdatePublished92020-12-042016-03-11In Commercial Distribution04710961932567PrimaryGS114710961932564Unit of UseGS1Silicone 3-way Foley Balloon Catheter (Standard Balloon)1830-0522656763489FORTUNE MEDICAL INSTRUMENT CORP.10falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsetrueLabeling does not contain MRI Safety InformationfalsefalseK98091900034917Indwelling 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, Balloontruefalse