Comfortcyn Advanced 86027

GUDID 20850015491768

Sonoma Pharmaceuticals, Inc.

Non-antimicrobial wound irrigation solution, multiple solute

• Primary Device ID: 20850015491768
• NIH Device Record Key: 5dd9eb92-1a72-49d4-b4f8-81502fb29779
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfortcyn Advanced
• Version Model Number: 86027
• Catalog Number: 86027
• 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: 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: 118 Milliliter
• Total Volume: 118 Milliliter
• Total Volume: 118 Milliliter
• Total Volume: 118 Milliliter
• Total Volume: 118 Milliliter
• Total Volume: 118 Milliliter
• Total Volume: 118 Milliliter
• Total Volume: 118 Milliliter
• Total Volume: 118 Milliliter
• Total Volume: 118 Milliliter
• Total Volume: 118 Milliliter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015491764 [Primary]
GS1	20850015491768 [Package]; Contains: 00850015491764; Package: Box [24 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: 2024-09-12
• Device Publish Date: 2024-09-04

Devices Manufactured by Sonoma Pharmaceuticals, Inc.

• 20850015491751 - Ocucyn Eyelid & Eyelash Cleanser: 2024-09-12
• 20850015491768 - Comfortcyn Advanced: 2024-09-12
• 20850015491768 - Comfortcyn Advanced: 2024-09-12
• 20850015491737 - Lumacyn: 2024-07-05
• 20850034960009 - Dr. Burd's Wonder Spray: 2023-09-15
• 20850034960016 - Dr. Burd's Wonder Spray: 2023-09-15
• 20850015491621 - Rejuvacyn Plus Antipruritic Spray Gel: 2023-05-15
• 20850015491638 - Rejuvacyn Plus Dermal Spray: 2023-05-15
• 20850015491645 - Rejuvacyn Plus Dermal Spray: 2023-05-15