CoolAdvantage Plus Card

Basic Information

• Brand Name: CoolAdvantage Plus Card
• Primary DI: 00816417020780
• Version / Model: BRZ-CD4-180-008
• Catalog Number: BRZ-CD4-180-008
• Company Name: Zeltiq Aesthetics, Inc.
• Labeler DUNS: 809152916
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-07
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4d67053b-38a6-47b5-9e42-c36448028b73

Device Description

CoolAdvantage Plus, CD4, Direct, 8 Cycles

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: Yes
• Has Lot/Batch Number: No
• 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
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	878.4340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56312	Cryolipolysis body contouring system program card	A portable electronic device designed to connect to the data port of a cryolipolysis body contouring system to provide its control unit with a selected treatment profile. It contains data such as cooling intensity factor (CIF), cycle time and other relevant treatment data, and is factory programmed so that the data cannot be modified. It is made of metal and plastic materials and has a connector at one end to connect to computerized devices. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816417020780	GS1

Customer Contacts

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