SmartMouth

GUDID 00697366003570

SmartMouth DryMouth Rehydrating Oral Rinse with artificial saliva for use in the oral cavity.

Triumph Pharmaceuticals Inc.

Artificial saliva

• Primary Device ID: 00697366003570
• NIH Device Record Key: 48ba89fc-9c39-472a-ac07-771a0477f4d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartMouth
• Version Model Number: SM.DR480
• Company DUNS: 017853461
• Company Name: Triumph 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: true
• 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

Customer Support Contacts

• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com
• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com
• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com
• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com
• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com
• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com
• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com
• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com
• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com
• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com
• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com
• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com
• Phone: +1(314)995-3090
• Email: cservice@smartmouth.com

Device Dimensions

• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter
• Total Volume: 480 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00697366003556 [Primary]
GS1	00697366003570 [Package]; Contains: 00697366003556; Package: Case [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181194

FDA Product Code

• LFD: Saliva, artificial

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: 2025-06-18
• Device Publish Date: 2025-06-10