Collector, Urine, Powered, Non Indwelling Catheter
Medical specialty
Gastroenterology, Urology
Device class
1
Regulation number
876.5250
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
Y
Third party review
N
Summary malfunction reporting
Eligible
Definition
For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair.