Scinus Cell Expansion System
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Basic Information
- Brand Name
- Scinus Cell Expansion System
- Primary DI
- 08720299213609
- Version / Model
- VCL3123001
- Company Name
- Scinus Cell Expansion Netherlands B.V.
- Labeler DUNS
- 493047487
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-08
- Public Version
- 1
- Public Version Date
- 2020-12-16
- Public Version Status
- New
- Public Device Record Key
- 7c23bdfd-29fd-4436-978c-812aed1be14d
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KJF | System, Suspension, Cell Culture | Hematology | 864.2240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61868 | Cell culture bioreactor | A mains electricity (AC-powered) laboratory instrument designed to cultivate adherent and/or suspension cells for various applications (e.g., T-cell expansion, mesenchymal stem cell expansion, dendritic cell maturation). It consists of a functionally closed hollow compartment with inputs/outputs for cell feeding, media exchange, waste removal and cell harvesting, and typically permits regulation of environmental factors that affect cell growth [e.g., temperature, pH, gas composition]. The device operates with minimal technician input and complete automation of all procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08720299213609 | GS1 |