Model: 626MR1010
DI: 00858290006987
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Allday Oral Moisturizing Rinse, 10oz Bottle
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3b9cbaa0-4216-44a0-be80-2544f7593e9d
Distribution Status:
In Commercial Distribution
DUNS Number:
002863526
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00858290006987
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37576
Name: Artificial saliva
Definition:
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.
FDA Product Codes
LFD
Saliva, Artificial
Premarket Submissions
Submission Number:
K150074
Supplement Number:
000