2L MC Bottle

Basic Information

• Brand Name: 2L MC Bottle
• Primary DI: 08720299213647
• Version / Model: 2LM-04-01
• Company Name: Scinus Cell Expansion Netherlands B.V.
• Labeler DUNS: 493047487
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-14
• Public Version: 1
• Public Version Date: 2021-01-22
• Public Version Status: New
• Public Device Record Key: 1fbf9f16-3268-4e32-8abf-12ff45e6797b

Device Description

This bottle can be used for the hydration of microcarriers and to reconstitute them in medium. And, the addition of the microcarriers to the Adherent Bag.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KJF	System, Suspension, Cell Culture	Hematology	864.2240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35734	Laboratory liquid dispenser, manual	A manual laboratory device designed to dispense fluid from a stock reservoir (e.g., a bottle or other container). The user determines the intended volume, typically up to 100 ml, by operating a manual pump. This device may be hand-held, or fitted to a bottle or alternative reservoir.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08720299213647	GS1