AccessGUDID - DEVICE: Scinus Cell Expansion System (08720299213609)

GUDID

Device Identifier (DI) Information

Brand Name: Scinus Cell Expansion System
Version or Model: VCL3123001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Scinus Cell Expansion Netherlands B.V.

Primary DI Number: 08720299213609
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 493047487 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61868	Cell culture bioreactor	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KJF	System, Suspension, Cell Culture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7c23bdfd-29fd-4436-978c-812aed1be14d
Public Version Date: December 16, 2020
Public Version Number: 1
DI Record Publish Date: December 08, 2020