3CP™ Counterbalance

Basic Information

• Brand Name: 3CP™ Counterbalance
• Primary DI: 05714188301808
• Version / Model: 2
• Company Name: Reapplix ApS
• Labeler DUNS: 312293991
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-23
• Public Version: 2
• Public Version Date: 2023-04-27
• Public Version Status: Update
• Public Device Record Key: b58ae14c-f92e-40d3-9552-375321719035

Device Description

Used with 3CP Centrifuge to counterbalance weight of 3C Patch Device(s).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62346	Centrifuge tube counterbalance	A device in the form of a centrifuge tube intended to balance weight across a centrifuge rotor when processing uneven numbers of tubes or tubes containing different volumes of fluid. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05714188301808	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]