| Device Type ID | 1728 |
| Device Name | Bag, Urine Collection, Leg, For External Use, Sterile |
| 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 | FAQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1728 |
| Device | Bag, Urine Collection, Leg, For External Use, Sterile |
| Product Code | FAQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urine Collector And Accessories. |
| CFR Regulation Number | 876.5250 [🔎] |
| Device Problems | |
|---|---|
Restricted Flow Rate | 2 |
Obstruction Of Flow | 2 |
Occlusion Within Device | 1 |
Patient-Device Incompatibility | 1 |
Folded | 1 |
| Total Device Problems | 7 |