Scinus Cell Expansion System

GUDID 08720299213609

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.

Scinus Cell Expansion Netherlands B.V.

Cell culture bioreactor

• Primary Device ID: 08720299213609
• NIH Device Record Key: 7c23bdfd-29fd-4436-978c-812aed1be14d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scinus Cell Expansion System
• Version Model Number: VCL3123001
• Company DUNS: 493047487
• Company Name: Scinus Cell Expansion Netherlands B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08720299213609 [Primary]

FDA Product Code

• KJF: System, Suspension, Cell Culture

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-16
• Device Publish Date: 2020-12-08

On-Brand Devices [Scinus Cell Expansion System]

• 08720299213609: The SCINUS consists of a cabinet that encloses a temperature-controlled environment where a Sing
• 08720299213616: For the adherent cell culture inside the SCINUS the Adherent Bag is used. This Adherent Bag is i