Definition: Urine Collector And Accessories; See Product Code FAQ.
| Device Type ID | 2033 |
| Device Name | Bag, Urine Collection, Leg, For External Use, Non-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 | NNW |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2033 |
| Device | Bag, Urine Collection, Leg, For External Use, Non-sterile |
| Product Code | NNW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urine Collector And Accessories. |
| CFR Regulation Number | 876.5250 [🔎] |
| Device Problems | |
|---|---|
Restricted Flow Rate | 1 |
Patient-Device Incompatibility | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Coloplast Manufacturing US, LLC | II | Oct-30-2014 |
| 2 | Purewick Corporation | II | Mar-06-2017 |