CoolSculpting Base Module

Basic Information

• Brand Name: CoolSculpting Base Module
• Primary DI: 00816417020025
• Version / Model: BRZ-CG1-BAM-110
• Catalog Number: BRZ-CG1-BAM-110
• Company Name: Zeltiq Aesthetics, Inc.
• Labeler DUNS: 809152916
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 634f3c84-9abf-407b-9efa-fad95ba9de85

Device Description

Control Unit

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
56308	Cryolipolysis body contouring system control unit	A mains electricity (AC-powered) component of a cryolipolysis body contouring system designed to allow the operator to adjust and control the operating functions of the system during cold-assisted lipolysis treatment (coolsculpting) to regulate the cooling modes, create the applied vacuum, and monitor the procedure. An applicator that delivers the thermal energy to the body is connected to this device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816417020025	GS1

Customer Contacts

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