Scinus Cell Expansion System

GUDID 08720299213616

For the adherent cell culture inside the SCINUS the Adherent Bag is used. This Adherent Bag is intended exclusively for use with the SCINUS. The SCINUS is a closed, controlled bioreactor system for automated cell cultivation. Combined with the Adherent Bag, it allows large-fold cell expansion without passing the cells due to its unique expansion technology. The SCINUS is operated by a controller, which is accessible through an integrated graphical user interface (GUI). The unique combination of the rocker, roller, and Adherent Bag ensures a homogenous environment with minimal levels of shear forces. The roller on top of the rocker enables the expansion of the available culture volume and surface area. The pH and dissolved oxygen (DO) levels are measured by integrated sensors in the Adherent Bag and are controlled with the controller software. The carboxygenator ensures that the set points are maintained within the desired bandwidths. For the culture of adherent cells, the Adherent Bag must be installed in the SCINUS. The Adherent Bag contains the culture bag and the corresponding weldable tubing set. One of the unique features of the Adherent Bag is the gradual expansion of the cell culture volume. The volume can be increased from a minimal volume of 0.1 L to 1.4 L to accommodate the growing cell population.

Scinus Cell Expansion Netherlands B.V.

Blood/tissue storage/culture container

• Primary Device ID: 08720299213616
• NIH Device Record Key: 06c8caaf-7233-48a2-8105-3f13f5467f17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scinus Cell Expansion System
• Version Model Number: ADH-01-01
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	08720299213616 [Primary]

FDA Product Code

• KJF: System, Suspension, Cell Culture

Sterilization

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

[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

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[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

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[08720299213616]

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[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

[08720299213616]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-17
• Device Publish Date: 2020-12-09

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