PhaseOne Antimicrobial Solution 15235

GUDID 10860009268606

Sonoma Pharmaceuticals, Inc.

Non-antimicrobial wound irrigation solution, multiple solute

• Primary Device ID: 10860009268606
• NIH Device Record Key: d85734a5-75d1-4f41-9cc0-2d06b79a5004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PhaseOne Antimicrobial Solution
• Version Model Number: 15235
• Catalog Number: 15235
• Company DUNS: 081642964
• Company Name: Sonoma Pharmaceuticals, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce
• Total Volume: 8 Fluid Ounce

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009268609 [Primary]
GS1	10860009268606 [Package]; Contains: 00860009268609; Package: Box [4 Units]; In Commercial Distribution

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: 2025-07-18
• Device Publish Date: 2025-07-10

On-Brand Devices [PhaseOne Antimicrobial Solution]

• 00860009268616: 15050
• 10860009268606: 15235
• 10850015491839: 15473