a1048d30-1a5e-4ced-99cd-fd5b4b927b82NewPublished12021-09-062021-08-28In Commercial Distribution00862563003122PrimaryGS1inFlow DeviceMarch 2017203511-50005928578VESIFLO INC1Intraurethral Valve-PumpfalsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsetrueMR UnsafetruefalseDEN13004400062305Intraurethral valve/pumpA sterile, non-powered device intended to be inserted into the female urethra to facilitate urine voiding in patients with incomplete bladder emptying due to impaired detrusor contractility (IDC) of neurologic origin. It is a tube, held in place at the bladder neck, containing a pump and valve. Its function as a pump to achieve urinary voiding, and as a valve to prevent urine leakage (incontinence) between voids, is controlled by a battery-powered, magnetically-coupled remote control. This is a single-patient device intended to be left in situ for up to 29 days before being discarded (single-use) and replaced.falseActivePIHUrethral Insert With Pump For Bladder DrainagetruetrueRadiation Sterilization