Home GUDID 00860014652165 Itus Mouthguardz
Primary DI 00860014652165
Brand Itus Mouthguardz
Company Shinrin-Yoku Traders LLC
Model SilentZPro 3.0
Catalog number B0HBXJQ616
Device description Anti-snore mouthguard
Published 2026-10-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name LRK Device, Anti-Snoring
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LRK Device, Anti-Snoring Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860014652165 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860014652165 00860014652165 860014652165 0860014652165
GMDN Terms# Term, Definition table Term Definition Breathing mouthpiece, reusable A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use.
Regulatory Flags# DUNS number 117177695 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860014652172 Itus Mouthguardz SilentZPro 3.0 (BlueTech) B0HBQYGZ8B 2026-10-28 00860014652103 Itus Mouthguardz SilentZzz, Clear, Sm SilentZzz, Clear, Sm 2026-04-06 00860014652110 Itus Mouthguardz SilentZzz, Clear, Md SilentZzz, Clear, Md 2026-04-06 00860014652127 Itus Mouthguardz SilentZzz, Clear, Lg SingleZzz Large 2026-04-06 00860002336572 Itus Mouthguardz SilentZPro 2.0 (Medium) B0F4P4M9CR 2025-05-01 00860002336503 Itus Mouthguardz SilentZPro 2.0 (Large) B0BQQKLPDQ 2025-02-01 00860002336558 Itus Mouthguardz SilentZPro 2.0 (BlueTech) B0DCTJ1DK3 2025-02-01 00860002336565 Itus Mouthguardz SilentZPro 2.0 (Small) B0DS1YFXFM 2025-02-01 00860002336596 Itus Mouthguardz SilentZPro 2.0 (with clips, medium) B0F4P7XQMC 2025-08-25
Other Devices Sharing Product Codes# 
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