Brella CB-1051

GUDID 00860009462274

Two count (CB-1067) a skin patch for the treatment of hyperhidrosis in a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis

Candesant Biomedical, Inc.

Antiperspirant

• Primary Device ID: 00860009462274
• NIH Device Record Key: 0517103a-7e04-486c-8ea3-371c7c2f06f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brella
• Version Model Number: CB-1051
• Catalog Number: CB-1051
• Company DUNS: 080125402
• Company Name: Candesant Biomedical, Inc.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com
• Phone: (223) 667-9328
• Email: info@candesant.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009462236 [Primary]
GS1	00860009462274 [Unit of Use]

FDA Product Code

• QVX: Skin Patch For Treatment Of Hyperhidrosis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-09
• Device Publish Date: 2023-09-29

On-Brand Devices [Brella]

• 00860009462212: A single use deactivation container for the deactivation of a skin patch for treatment of hyperh
• 00860009462298: A two count (CB-1068) single use deactivation container kit for the deactivation of a skin patch
• 00860009462281: A ten count (CB-1068) single use deactivation container kit for the deactivation of a skin patch
• 00860009462274: Two count (CB-1067) a skin patch for the treatment of hyperhidrosis in a prescription topical pa
• 00860009462229: Ten count (CB-1067) a skin patch for the treatment of hyperhidrosis in a prescription topical pa
• 00860009462205: A skin patch for treatment of hyperhidrosis in a prescription topical patch that utilizes a chem