| Device Type ID | 2577 |
| Device Name | Stand, Infusion |
| Regulation Description | Infusion Stand. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.6990 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FOX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2577 |
| Device | Stand, Infusion |
| Product Code | FOX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Infusion Stand. |
| CFR Regulation Number | 880.6990 [🔎] |
| Device Problems | |
|---|---|
Crack | 4 |
Fluid Leak | 3 |
Mechanical Problem | 2 |
Detachment Of Device Component | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Failure To Run On AC/DC | 1 |
Defective Component | 1 |
Stand | 1 |
Power Supply | 1 |
Failure To Charge | 1 |
Device Tipped Over | 1 |
| Total Device Problems | 18 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EKOS Corporation | II | Sep-27-2016 |
| 2 | Firefly Medical, Inc. | II | Sep-07-2017 |
| 3 | Firefly Medical, Inc. | II | Dec-15-2016 |
| 4 | Ohmeda Medical | II | Mar-26-2018 |
| 5 | Stryker Medical Division Of Stryker Corporation | II | Nov-30-2015 |