MuGard

GUDID 00860013569907

MuGard Mucoadhesive Oral Wound Rinse (MuGard) is a non-sterile slightly viscous liquid consisting of film-forming polymers, humectant and dispersion aids, preservatives, sweeteners/flavors and pH modifiers, namely: carbomer homopolymer A, polysorbate 60, glycerin, benzyl alcohol, citric acid, sodium saccharin, potassium hydroxide, and phosphoric acid. The rinse solution is supplied in a flat, white, opaque, eight fluid ounce, high-density polyethylene (HDPE) bottle.

Soleva Pharma LLC

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00860013569907
• NIH Device Record Key: a61a3b7a-32f7-468e-a1b0-15f390e54ae5
• Commercial Distribution Discontinuation: 2026-11-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MuGard
• Version Model Number: Mucoadhesive Oral Wound Rinse
• Company DUNS: 063304531
• Company Name: Soleva Pharma LLC
• 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com
• Phone: 877-319-7272
• Email: medinfo@solevapharma.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013569907 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062795

FDA Product Code

• MGQ: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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: 2025-03-10
• Device Publish Date: 2025-02-28