Definition: Urine Collector And Accessories; See Product Code EXJ
| Device Type ID | 2034 |
| Device Name | Device, Incontinence, Urosheath Type, 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 | NNX |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2034 |
| Device | Device, Incontinence, Urosheath Type, Non-sterile |
| Product Code | NNX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urine Collector And Accessories. |
| CFR Regulation Number | 876.5250 [🔎] |
| Device Problems | |
|---|---|
Nonstandard Device | 116 |
Patient-Device Incompatibility | 12 |
Component Missing | 4 |
Inadequate Instructions For Healthcare Professional | 2 |
Difficult To Remove | 2 |
Expiration Date Error | 1 |
Inaccurate Flow Rate | 1 |
Shipping Damage Or Problem | 1 |
No Flow | 1 |
Collapse | 1 |
Pressure Problem | 1 |
| Total Device Problems | 142 |