Sonu (Black Headband)

Basic Information

• Brand Name: Sonu (Black Headband)
• Primary DI: 00860009781207
• Version / Model: SHS-HW-001B
• Company Name: Sound Health Systems Inc
• Labeler DUNS: 117419757
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-09
• Public Version: 1
• Public Version Date: 2024-03-18
• Public Version Status: New
• Public Device Record Key: f16be997-b23c-4bf5-99e1-92435ef07c52

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QZC	External Mechanical Stimulator For The Relief Of Congestion	Ear, Nose, Throat	874.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35368	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009781207	GS1
Package	10860009781204	GS1	Carton	12	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
DEN230045	000