1L Bottle

Basic Information

• Brand Name: 1L Bottle
• Primary DI: 08720299213623
• Version / Model: 1LB-02-01
• 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: 5cda73d0-c37e-411a-8095-ce8d59fa6ea7

Device Description

This bottle can be used for the addition and removal of liquids to/from e.g. the Adherent Bag. (single-use)

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: No
• 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	08720299213623	GS1