| Device Type ID | 1802 |
| Device Name | Device, Urine Flow Rate Measuring, Non-electrical, Disposable |
| Regulation Description | Urine Flow Or Volume Measuring System. |
| 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 | 876.1800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FFG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1802 |
| Device | Device, Urine Flow Rate Measuring, Non-electrical, Disposable |
| Product Code | FFG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urine Flow Or Volume Measuring System. |
| CFR Regulation Number | 876.1800 [🔎] |
| Device Problems | |
|---|---|
No Flow | 75 |
Break | 27 |
Leak / Splash | 25 |
Device Operates Differently Than Expected | 20 |
Occlusion Within Device | 17 |
Fluid Leak | 12 |
Defective Device | 11 |
Infusion Or Flow Problem | 11 |
Device Contamination With Chemical Or Other Material | 10 |
Restricted Flow Rate | 8 |
Device Damaged Prior To Use | 7 |
Detachment Of Device Component | 7 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 7 |
Fracture | 6 |
Improper Flow Or Infusion | 6 |
Crack | 6 |
Material Separation | 5 |
Delivered As Unsterile Product | 5 |
Improper Device Output | 4 |
Partial Blockage | 4 |
Disconnection | 4 |
Collapse | 3 |
Product Quality Problem | 3 |
Defective Component | 3 |
Tear, Rip Or Hole In Device Packaging | 3 |
Measurement System Incompatibility | 3 |
Connection Problem | 3 |
Biofilm Coating In Device | 3 |
Obstruction Of Flow | 3 |
Use Of Device Problem | 2 |
Component Missing | 2 |
Detachment Of Device Or Device Component | 2 |
Insufficient Flow Or Under Infusion | 2 |
Unsealed Device Packaging | 2 |
Device Packaging Compromised | 2 |
Out-Of-Box Failure | 1 |
Tube | 1 |
Positioning Failure | 1 |
Material Fragmentation | 1 |
Device Contamination With Biological Material | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Kinked | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Positioning Problem | 1 |
Filling Problem | 1 |
Difficult To Open Or Close | 1 |
Catheter | 1 |
Shipping Damage Or Problem | 1 |
Difficult Or Delayed Positioning | 1 |
Contamination During Use | 1 |
Decoupling | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 330 |