Brella

Basic Information

• Brand Name: Brella
• Primary DI: 00860009462205
• Version / Model: CB-1067
• Catalog Number: CB-1067
• Company Name: Candesant Biomedical, Inc.
• Labeler DUNS: 080125402
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-29
• Public Version: 1
• Public Version Date: 2023-10-09
• Public Version Status: New
• Public Device Record Key: f98ad208-363f-4f8c-9602-26b3d4cba742

Device Description

A skin patch for treatment of hyperhidrosis in a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis.

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QVX	Skin Patch For Treatment Of Hyperhidrosis	General, Plastic Surgery	878.4425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61257	Antiperspirant	A substance (e.g., gel, solution, cream) intended to be topically applied to the skin (e.g., underarms, hands, feet) to prevent sweating, typically as a treatment for hyperhidrosis. It includes aluminium compounds (e.g., aluminium chloride hexahydrate) and is intended to block the sweat pores through formation of a gel. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009462205	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Oval shape with width 2.75" and length 5"

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry