FDA UDI
In Commercial Distribution
🇺🇸 United States
Nexodyn Antimicrobial Wound Care Solution
DI: 07640158091678
·
Model: 3.5 fl. oz. (100ml) with spray pump
·
APR Applied Pharma Research SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nexodyn Antimicrobial Wound Care Solution
- Primary DI
- 07640158091678
- Version / Model
- 3.5 fl. oz. (100ml) with spray pump
- Company Name
- APR Applied Pharma Research SA
- Labeler DUNS
- 482198926
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-06
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 4e95e444-0869-42ee-9618-3f6bf56377e3
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 07640158091678 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151168 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- NexodynTM Antimicrobial Wound Care Solution should be stored in a dry place, protected from sunlight and heat, in its original sealed bottle and carton between 41 °F and 77 °F (5 °C and 25 °C).
- Type
- Special Storage Condition, Specify
- Special Conditions
- Nexodyn Antimicrobial wound Care Solution is not-flammable. Special storage precautions are not needed. After use, the container should be secured with the screw cap or, if the spray pump is fitted
- Type
- Special Storage Condition, Specify
- Special Conditions
- Special handling precautions are not required if NexodynTM Antimicrobial Wound Care Solution is used in accordance with instructions of the leaflet.