The SCINUS consists of a cabinet that encloses a temperature-controlled environment where a Single Use Bag can be mounted on a mixing Rocker. At the front of the cabinet, the transparent…
The SCINUS consists of a cabinet that encloses a temperature-controlled environment where a Single Use Bag can be mounted on a mixing Rocker. At the front of the cabinet, the transparent door allows access to the internal area. When opening the transparent front door, the motor of the Rocker will be switched off. In this way, a hazardous situation is prevented. At the left side of the SCINUS front panel, the Emergency Stop button is located, together with the Illumination button and the Control Panel (touch screen display that is used as Graphical User Interface). On the top of the SCINUS, four mounting positions are available for insertion of lifting lugs. The mounting positions are covered and lifting lugs are not provided with the system.
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for Scinus Cell Expansion System | Listed by | Scinus Cell Expansion Netherlands B.V. |
| FDA product code | KJF |
| Device type | System, Suspension, Cell Culture |
| Device class | Class 1 |
| Regulation | 21 CFR 864.2240 |
| Premarket notification | Exempt |
| Record published | 2020-12-08 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | manufacturing date, serial number |
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.