| Device Type ID | 1961 |
| Device Name | Collector, Urine, (and Accessories) 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 | KNX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1961 |
| Device | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Product Code | KNX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urine Collector And Accessories. |
| CFR Regulation Number | 876.5250 [🔎] |
| Device Problems | |
|---|---|
Restricted Flow Rate | 99 |
Patient-Device Incompatibility | 9 |
Deformation Due To Compressive Stress | 8 |
Partial Blockage | 6 |
Device Contamination With Chemical Or Other Material | 5 |
Fluid Leak | 5 |
Material Twisted / Bent | 5 |
Deflation Problem | 4 |
Labelling, Instructions For Use Or Training Problem | 4 |
Device Contaminated During Manufacture Or Shipping | 2 |
Inadequate Instructions For Healthcare Professional | 2 |
Appropriate Term/Code Not Available | 2 |
Bags | 2 |
Misassembled | 2 |
Delivered As Unsterile Product | 2 |
Occlusion Within Device | 1 |
Self-Activation Or Keying | 1 |
Connection Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Seal | 1 |
Difficult To Open Or Close | 1 |
No Flow | 1 |
Component Missing | 1 |
Obstruction Of Flow | 1 |
Device Operates Differently Than Expected | 1 |
Infusion Or Flow Problem | 1 |
Failure To Capture | 1 |
Leak / Splash | 1 |
Hole In Material | 1 |
Computer Operating System Problem | 1 |
Device Packaging Compromised | 1 |
Nonstandard Device | 1 |
Overheating Of Device | 1 |
Insufficient Information | 1 |
Kinked | 1 |
Disconnection | 1 |
| Total Device Problems | 178 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | C.R. Bard, Inc. | II | Aug-10-2017 |
| 2 | C.R. Bard, Inc. | II | Jan-09-2017 |
| 3 | C.R. Bard, Inc. | III | Aug-03-2016 |
| 4 | C.R. Bard, Inc. | II | Apr-01-2015 |
| 5 | Customed, Inc | II | Sep-03-2015 |