Solventum™ Nu-Gel™ MNG425V003

GUDID 00197998326981

Solventum™ Nu-Gel™ Hydrogel with Alginate, MNG425, 0.88 oz (25 g), 6/CAR, 4 CAR/CS, 24/CS

Solventum US LLC

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00197998326981
• NIH Device Record Key: b9223d9c-ee52-4024-87ae-eea068e31e00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solventum™ Nu-Gel™
• Version Model Number: MNG425V003
• Catalog Number: MNG425V003
• Company DUNS: 119004140
• Company Name: Solventum US LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: false

Customer Support Contacts

• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197998326967 [Primary]
GS1	00197998326981 [Package]; Contains: 00197998326967; Package: CASE [24 Units]; In Commercial Distribution

FDA Product Code

• NAE: Dressing, wound, hydrogel without drug and/or biologic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-30
• Device Publish Date: 2025-09-22

On-Brand Devices [Solventum™ Nu-Gel™]

• 00197998326981: Solventum™ Nu-Gel™ Hydrogel with Alginate, MNG425, 0.88 oz (25 g), 6/CAR, 4 CAR/CS, 24/CS
• 00197998326905: Solventum™ Nu-Gel™ Hydrogel with Alginate, MNG415, 0.52 oz (15 g), 10/CAR, 4 CAR/CS, 40/CS