FDA UDI
In Commercial Distribution
🇺🇸 United States
Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container
DI: 00851383003146
·
Model: 00314
·
URGO MEDICAL NORTH AMERICA, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container
- Primary DI
- 00851383003146
- Version / Model
- 00314
- Catalog Number
- 00314
- Company Name
- URGO MEDICAL NORTH AMERICA, LLC
- Labeler DUNS
- 052758618
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-03
- Public Version
- 4
- Public Version Date
- 2026-01-06
- Public Version Status
- Update
- Public Device Record Key
- fa74aaa1-b5bf-4971-95ce-89b482261da4
Device Description
Vashe Wound Solution is a skin, wound, burn cleansing solution that is to be used for debridmement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 475 ml (16 fl oz) container size with a flip top cap.
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10851383003143 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00851383003146 | GS1 |
Customer Contacts
- Phone
- 855-888-8273
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131848 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 475 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from sunlight and heat
- Type
- Handling Environment Temperature
- Temperature Range
- 32 – 122 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 77 Degrees Fahrenheit