ELECTROCYN soma ES7100W

GUDID 09551012610066

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.

V3BIO SDN. BHD.

Antimicrobial wound irrigation solution

• Primary Device ID: 09551012610066
• NIH Device Record Key: 80942b0e-e94a-436b-8f40-977cdc497c51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELECTROCYN soma
• Version Model Number: ES7100W
• Catalog Number: ES7100W
• Company DUNS: 659301481
• Company Name: V3BIO SDN. BHD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09551012610066 [Primary]

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-16
• Device Publish Date: 2024-12-06

On-Brand Devices [ELECTROCYN soma]

• 09551012610318: ES1300W
• 09551012610295: ES4400W
• 09551012610059: ES5100W
• 09551012610042: ES4100W
• 09551012610028: ES3300W
• 09551012610066: ELECTROCYN soma is a medical device under category of wound wash and irrigation solution. The so