CloSYS Dry Mouth Sensitive Mouth Rinse

GUDID 00647692000132

Rowpar Pharmaceuticals, Inc.

Artificial saliva
Primary Device ID00647692000132
NIH Device Record Key43e524db-6840-45c7-82df-78bd3ff147cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCloSYS Dry Mouth Sensitive Mouth Rinse
Version Model NumberN/A
Company DUNS783704661
Company NameRowpar Pharmaceuticals, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-643-3337
Emailsupport@closys.com
Phone1-800-643-3337
Emailsupport@closys.com
Phone1-800-643-3337
Emailsupport@closys.com
Phone1-800-643-3337
Emailsupport@closys.com
Phone1-800-643-3337
Emailsupport@closys.com
Phone1-800-643-3337
Emailsupport@closys.com
Phone1-800-643-3337
Emailsupport@closys.com
Phone1-800-643-3337
Emailsupport@closys.com
Phone1-800-643-3337
Emailsupport@closys.com
Phone1-800-643-3337
Emailsupport@closys.com
Phone1-800-643-3337
Emailsupport@closys.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100647692000132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFDSaliva, Artificial

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-24
Device Publish Date2025-12-16

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.