DEVICE: Adherent Bag (08720299213616)
Device Identifier (DI) Information
Adherent Bag
ADH-01-01
In Commercial Distribution
Scinus Cell Expansion Netherlands B.V.
ADH-01-01
In Commercial Distribution
Scinus Cell Expansion Netherlands B.V.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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44904 | Blood/tissue storage/culture container |
A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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KJF | System, Suspension, Cell Culture |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
06c8caaf-7233-48a2-8105-3f13f5467f17
June 17, 2022
3
December 09, 2020
June 17, 2022
3
December 09, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined