FDA UDI
In Commercial Distribution
🇺🇸 United States
ELECTROCYN soma
DI: 09551012610295
·
Model: ES4400W
·
V3BIO SDN. BHD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELECTROCYN soma
- Primary DI
- 09551012610295
- Version / Model
- ES4400W
- Catalog Number
- ES4400W
- Company Name
- V3BIO SDN. BHD.
- Labeler DUNS
- 659301481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-01
- Public Version
- 2
- Public Version Date
- 2023-09-12
- Public Version Status
- Update
- Public Device Record Key
- a9324a3c-a994-42d1-83e9-65dd1495ee18
Device Description
ELECTROCYN soma is a medical device under category of wound wash and irrigation solution. The solution contains 99.9% purified water and with combined percentage of not more than 0.1% of Hypochlorous acid (HOCl) + Sodium hypochlorite (NaOCl) + sodium chloride (NaCl) which are produced by electrolysis technology with the use of purified water and purified salt. The primary intention of the ELECTROCYN soma solution is for mechanical debridement, irrigation, and moistening. The mechanical action of irrigating and debriding would assist in removing dead, damaged and contaminated tissues on and around the wound.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 | 09551012610295 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 250 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius