Home GUDID 10860009781259 Sonu (Gray Headband)
Primary DI 10860009781259
Brand Sonu (Gray Headband)
Company Sound Health Systems Inc
Model SHS-HW-001A
Device description Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 22 and older.
Published 2024-03-09
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 QZC External Mechanical Stimulator For The Relief Of Congestion
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QZC External Mechanical Stimulator For The Relief Of Congestion Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10860009781259 Package GS1 12 In Commercial Distribution 00860009781252 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 10860009781259 10860009781259 00860009781252 00860009781252 860009781252 0860009781252
GMDN Terms# Term, Definition table Term Definition Auditory stimulator A mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices.
Regulatory Flags# DUNS number 117419757 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false 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 00860009781252 Sonu (Gray Headband) SHS-HW-001A 2024-03-09 00860009781207 Sonu (Black Headband) SHS-HW-001B 2024-03-09
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860009781252 Sonu (Gray Headband) Sound Health Systems Inc QZC 2024-03-09 00860009781207 Sonu (Black Headband) Sound Health Systems Inc QZC 2024-03-09