Silicone Supra-Pubic Catheter (Integrated Balloon)

Device typeSuprapubic drainage catheter: A flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device.

FDA categoryCatheter, Suprapubic (And Accessories)

Device ID04710961937548

Single useYes

SterileYes

LatexNot made with natural rubber latex

MRI safetyLabeling does not contain MRI Safety Information