Device typeUrinary catheter ultrasonic bacterial adhesion inhibition system actuator: A non-sterile, portable, noninvasive device designed to generate and deliver ultrasonic vibrations to the external portion of an indwelling urethral catheter to inhibit bacterial attachment/biofilm formation on the catheter surface to reduce risk of infection within the urinary tract. It is a small unit with a transducer and integrated ultrasonic actuator intended to be attached (e.g., clipped onto) the catheter. It is designed to be used with a system control unit (not included) from which it is controlled and draws power. This is a single-use device.
FDA categoryExtracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During The Covid-19 Pandemic
Device ID07290103420116
Catalog number10-600-0003
AvailabilityPrescription
Single useYes
MRI safetyMR Unsafe