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.
| Device Type ID | 2059 |
| Device Name | Collector, Urine, Powered, Non Indwelling Catheter |
| Physical State | The Device Consists Of A Female Designed Cup, Male Cup, Collection Tubing, Urine Bag, Pump, Rechargeable Batter, Circuitry To Control The Operaton Of The Pump, Software, And Carrying Case To Be Attached To A Wheel Chair Or Beside. |
| Technical Method | Urine Is Collected In A Collection Cup And With The Assistance Of A Battery Powered Pump The Urine Is Drawn Through Tubing Into A Urine Bag For Storage. |
| Target Area | The Collection Cup Is Place Under The External Meatus Of The Urethra |
| Regulation Description | Urine Collector And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.5250 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NZU |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2059 |
| Device | Collector, Urine, Powered, Non Indwelling Catheter |
| Product Code | NZU |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urine Collector And Accessories. |
| CFR Regulation Number | 876.5250 [🔎] |
| Device Problems | |
|---|---|
Patient-Device Incompatibility | 10 |
Increase In Suction | 3 |
Labelling, Instructions For Use Or Training Problem | 3 |
Disconnection | 1 |
| Total Device Problems | 17 |