| Device Type ID | 1803 |
| Device Name | Collector, Urine, Pediatric, For Indwelling Catheter |
| 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 2 Medical Device |
| Product Code | FFH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1803 |
| Device | Collector, Urine, Pediatric, For Indwelling Catheter |
| Product Code | FFH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urine Collector And Accessories. |
| CFR Regulation Number | 876.5250 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Inaccurate Flow Rate | 3 |
Patient-Device Incompatibility | 1 |
Material Twisted / Bent | 1 |
Misassembled | 1 |
Use Of Device Problem | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Break | 1 |
Gel Leak | 1 |
| Total Device Problems | 14 |