FDA UDI
In Commercial Distribution
🇺🇸 United States
Avenova
DI: 00857005004232
·
Model: NBY 101-6
·
NOVABAY PHARMACEUTICALS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Avenova
- Primary DI
- 00857005004232
- Version / Model
- NBY 101-6
- Catalog Number
- NBY 101-6
- Company Name
- NOVABAY PHARMACEUTICALS, INC.
- Labeler DUNS
- 191505192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-06
- Public Version
- 2
- Public Version Date
- 2023-07-17
- Public Version Status
- Update
- Public Device Record Key
- 4663e37b-3b29-4d47-861f-082d9fd1fec7
Device Description
Avenova OTC 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59523 | Antimicrobial wound irrigation solution | A solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. 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 | 00857005004232 | GS1 |
Customer Contacts
- Phone
- 1-800-890-0329
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131542 | 000 |