Adherent Bag

Primary DI
08720299213616
Brand
Adherent Bag
Company
Scinus Cell Expansion Netherlands B.V.
Model
ADH-01-01
Device description
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.
Published
2020-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KJFSystem, Suspension, Cell Culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJFSystem, Suspension, Cell CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720299213616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720299213616087202992136168720299213616

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA durable, sterile plastic container with ports, or glass bottle, 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. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
493047487
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
087202992136231L Bottle1LB-02-012021-01-14
087202992136302L Buffer Bottle2LB-03-012021-01-14
087202992136472L MC Bottle2LM-04-012021-01-14
08720299213609Scinus Cell Expansion SystemVCL31230012020-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850019717471G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717518G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717648G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717488G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717525G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717655G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717624G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2025-06-09
00850019717631G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2025-06-09
00850019717563G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-03-08
00850019717570G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-03-08
00850019717600G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-02-14
00850019717617G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-02-14
00850019717587G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-02-13
00850019717495G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717532G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717501G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717549G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00854498007986Save-A-ToothSmarthealth, Inc.KJF2023-04-03
00850019717457G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-02-20
00850019717464G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-02-20
00850019717556G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-02-09
00850019717419G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-16
00850019717426G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-16
00850019717174G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-14
00850019717181G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-14
00850019717280G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-03
00850019717297G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-03
00850019717150G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12
00850019717396G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12
00850019717167G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12