Avenova NBY 101-6

GUDID 00857005004232

Avenova OTC is a clear liquid solution cleanser compromised of hypochlorous acid (HOCl) 0.01% in saline. The solution is provided in a glass bottle with a pump provided for use in spraying the solution.

NOVABAY PHARMACEUTICALS, INC.

Antimicrobial wound irrigation solution

• Primary Device ID: 00857005004232
• NIH Device Record Key: 4663e37b-3b29-4d47-861f-082d9fd1fec7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avenova
• Version Model Number: NBY 101-6
• Catalog Number: NBY 101-6
• Company DUNS: 191505192
• Company Name: NOVABAY PHARMACEUTICALS, INC.
• Device Count: 1
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com
• Phone: 1-800-890-0329
• Email: support@avenova.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857005004232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131542

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [Avenova]

• 00857005004232: Avenova OTC is a clear liquid solution cleanser compromised of hypochlorous acid (HOCl) 0.01% in
• 10857005004031: Avenova is a clear liquid solution cleanser compromised of hypochlorous acid (HOCl) 0.01% in sal
• 20857005004175: Avenova is a clear liquid solution cleanser composed of hypochlorous acid (HOCl) 0.01% in saline
• 00857005004195: Avenova is a clear liquid solution cleanser composed of hypochlorous acid (HOCl) 0.01% in saline