Definition: Infusion Safety Management Software Is A Prescription Device Intended For Use With Infusion Pumps And May Include One Or More Of The Following Capabilities: Prepopulation Of Infusion Programming Parameters, Data Retrieval And Analysis For Tracking An
| Device Type ID | 2742 |
| Device Name | Infusion Safety Management Software |
| Physical State | The Device Is A Software Application(s), Which May Be Implemented As Part Of An Infusion Pump And May Also Be Implemented Onto A Hospital Information System For Use With An Infusion Pump System. |
| Technical Method | Infusion Safety Management Software May Include One Or More Software Applications That Enforce Safety Control Mechanisms Through Wireless Or Wired Communication Between The Hospital Information System, The Infusion Pump, And The Healthcare Provider. |
| Target Area | Target Area Is According To The Approved Drug Or Biologic Product Labeling. |
| Regulation Description | Infusion Pump. |
| 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) |
| CFR Regulation Number | 880.5725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PHC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2742 |
| Device | Infusion Safety Management Software |
| Product Code | PHC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infusion Pump. |
| CFR Regulation Number | 880.5725 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITHS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITHS GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corporation | II | Oct-13-2018 |
| 2 | Becton Dickinson & Company | II | Mar-08-2016 |