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Avenova

FDA UDI

Class U (US FDA UDI)

by Novabay Pharmaceuticals, Inc

Identity

Trade Name
Avenova FDA UDI
Generic Name
Antimicrobial wound irrigation solution FDA UDI
Device Name
Avenova is a clear liquid solution cleanser composed 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. FDA UDI
Model / Reference
NBY 101-34 FDA UDI
Description
Avenova is a clear liquid solution cleanser composed 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. FDA UDI

Identifiers

Catalog Number
NBY 101-34 FDA UDI
Primary DI / UDI-DI
00857005004157 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Antimicrobial wound irrigation solution FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Antimicrobial wound irrigation solution

Avenova by Novabay Pharmaceuticals, Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Antimicrobial wound irrigation solution.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 9e3faeb8-c4d8-4ef1-bace-c77058b1160a 35 fields · synced May 30, 2026