FDA UDI
In Commercial Distribution
🇺🇸 United States
XPERIENCE
DI: 00370858000232
·
Model: MC-SL-0005-4D
·
NEXT SCIENCE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- XPERIENCE
- Primary DI
- 00370858000232
- Version / Model
- MC-SL-0005-4D
- Company Name
- NEXT SCIENCE, LLC
- Labeler DUNS
- 043989331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2021-04-28
- Public Version
- 2
- Public Version Date
- 2023-08-22
- Public Version Status
- Update
- Public Device Record Key
- 857a2195-8aff-43c5-ae72-d7a461e30ea6
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 58931 | Non-antimicrobial wound irrigation solution, multiple solute | A solution of electrolytes sometimes with other compounds [not limited to sodium chloride (NaCl), therefore not a saline solution], intended to be used to irrigate and clean a superficial skin wound to support natural healing; it is not intended to provide antimicrobial activity. The device may be supplied in a plastic container with a spray nozzle and 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00370858000140 | GS1 | ||||
| Primary | 00370858000232 | GS1 |
Customer Contacts
- Phone
- 855-564-2762
- [email protected]