3CP™ Counterbalance

Basic Information

• Brand Name: 3CP™ Counterbalance
• Primary DI: 05714188301822
• Version / Model: 1
• Company Name: Reapplix ApS
• Labeler DUNS: 312293991
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-19
• Public Version: 2
• Public Version Date: 2023-01-03
• Public Version Status: Update
• Public Device Record Key: 3ee0ca66-47a5-49f4-9cb0-2c4702cd7e67
• Distribution End Date: 2020-01-02

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
PMQ	Peripheral Blood Processing Device For Wound Management	Hematology	864.9245	2

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	05714188301822	GS1

Customer Contacts

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