AccessGUDID - DEVICE: SmartMouth (00697366003556)

GUDID

Device Identifier (DI) Information

Brand Name: SmartMouth
Version or Model: SM.DR480
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Triumph Pharmaceuticals Inc.

Primary DI Number: 00697366003556
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017853461 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37576	Artificial saliva	An electrolyte solution resembling human saliva designed in part to replace the normal ionic and pH balance of the oral cavity. The device is intended as a mouth rinse to moisten, lubricate, and clean the mucosa of the mouth, tongue, and throat. The device is indicated for dryness of the mouth or throat due to temporary or permanent conditions. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFD	Saliva, artificial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181194	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 480 Milliliter

Device Record Status

Public Device Record Key: 48ba89fc-9c39-472a-ac07-771a0477f4d4
Public Version Date: June 18, 2025
Public Version Number: 1
DI Record Publish Date: June 10, 2025