Duns Number:493047487
Device Description: For the adherent cell culture inside the SCINUS the Adherent Bag is used. ThisAdherent Bag For the adherent cell culture inside the SCINUS the Adherent Bag is used. ThisAdherent Bag is intended exclusively for use with the SCINUS.The SCINUS is a closed, controlled bioreactor system for automated cellcultivation. Combined with the Adherent Bag, it allows large-fold cell expansionwithout passing the cells due to its unique expansion technology. The SCINUSis operated by a controller, which is accessible through an integrated graphicaluser interface (GUI).The unique combination of the rocker, roller, and Adherent Bag ensures ahomogenous environment with minimal levels of shear forces. The roller on topof the rocker enables the expansion of the available culture volume and surfacearea. The pH and dissolved oxygen (DO) levels are measured by integratedsensors in the Adherent Bag and are controlled with the controller software.The carboxygenator ensures that the set points are maintained within thedesired bandwidths.For the culture of adherent cells, the Adherent Bag must be installed in the SCINUS. The AdherentBag contains the culture bag and the corresponding weldable tubing set.One of the unique features of the Adherent Bag is the gradual expansion of thecell culture volume. The volume can be increased from a minimal volume of 0.1 Lto 1.4 L to accommodate the growing cell population.
Catalog Number
-
Brand Name
Adherent Bag
Version/Model Number
ADH-01-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KJF
Product Code Name
System, Suspension, Cell Culture
Public Device Record Key
06c8caaf-7233-48a2-8105-3f13f5467f17
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
December 09, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |