Definition: Hemodialysis Tray
| Device Type ID | 2016 |
| Device Name | Kit, Repair, Catheter, Hemodialysis |
| Physical State | Hemodialysis Tray |
| Technical Method | Hemodialysis Tray |
| Target Area | Hemodialysis Tray |
| Regulation Description | Blood Access Device 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) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5540 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NFK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2016 |
| Device | Kit, Repair, Catheter, Hemodialysis |
| Product Code | NFK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Access Device And Accessories. |
| CFR Regulation Number | 876.5540 [🔎] |
| Device Problems | |
|---|---|
Crack | 13 |
Leak / Splash | 10 |
Material Integrity Problem | 2 |
Gas Leak | 2 |
Failure To Infuse | 1 |
Detachment Of Device Component | 1 |
Hole In Material | 1 |
Fluid Leak | 1 |
Break | 1 |
Moisture Or Humidity Problem | 1 |
| Total Device Problems | 33 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medical Components, Inc Dba MedComp | II | Mar-19-2018 |