Digistat Smart Central
Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party…
Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients’ status and alarm conditions when they are away from the patient and associated medical devices.
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
Record
| Listed by | Ascom UMS SRL, Italy |
|---|---|
| FDA product code | PHC |
| Device type | Infusion Safety Management Software |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Manufacturer |
| 510(k) | K180430 |
| Record published | 2019-03-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SW000754 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ivenix Infusion System | Fresenius Kabi AB | 6 |
| BD Intelliport | Becton, Dickinson AND Company | 5 |
| PharmGuard | ICU Medical, Inc | 4 |
| LifeShield Infusion Safety Software Suite | ICU Medical, Inc | 3 |
| Dose IQ Safety Software | Baxter Healthcare Corporation | 3 |
| Alaris | CareFusion 303, Inc | 3 |
| ICU Medical MedNet | ICU Medical, Inc | 3 |
| LifeShield Infusion Safety Software Suite – LifeShield CDR | ICU Medical, Inc | 2 |
| Alaris™ Guardrails™ Editor Software Kit, Model 8961 | CareFusion 303, Inc | 2 |
| BD Alaris | CareFusion 303, Inc | 1 |
| BD Alaris™ System Manager 9601, Software | CareFusion 303, Inc | 1 |
| Vigilant Software Suite | Fresenius Kabi AB | 1 |
Showing 12 of 20. All products under Infusion Safety Management Software
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.