FDA.reportPublic FDA data

Scinus Cell Expansion System

Primary DI
08720299213609
Brand
Scinus Cell Expansion System
Company
Scinus Cell Expansion Netherlands B.V.
Model
VCL3123001
Device description
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.
Published
2020-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08720299213609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720299213609087202992136098720299213609

GMDN Terms#

Term, Definition table
TermDefinition
Cell culture bioreactorA mains electricity (AC-powered) laboratory instrument designed to cultivate adherent and/or suspension cells for various applications (e.g., T-cell expansion, mesenchymal stem cell expansion, dendritic cell maturation). It consists of a functionally closed hollow compartment with inputs/outputs for cell feeding, media exchange, waste removal and cell harvesting, and typically permits regulation of environmental factors that affect cell growth [e.g., temperature, pH, gas composition]. The device operates with minimal technician input and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
493047487
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720299213616Adherent BagADH-01-012020-12-09
087202992136231L Bottle1LB-02-012021-01-14
087202992136302L Buffer Bottle2LB-03-012021-01-14
087202992136472L MC Bottle2LM-04-012021-01-14

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