Breathewave

Basic Information

• Brand Name: Breathewave
• Primary DI: 00860014485237
• Version / Model: Medium
• Company Name: BREATHEWAVE TECHNOLOGIES INC.
• Labeler DUNS: 138492599
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-23
• Public Version: 1
• Public Version Date: 2025-12-31
• Public Version Status: New
• Public Device Record Key: 33c8e110-4410-40a5-a510-022e084a8175

Device Description

Contoured Nasal Dilator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
LWF	Dilator, Nasal	Ear, Nose, Throat	874.3900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47607	Nasal breathing aid, internal, reusable	An internal device intended to improve breathing by decreasing nasal resistance, thus increasing nasal airflow. It is typically in the form of clip, constructed from metal or plastic, that is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella (fleshy external end of the nasal septum). The device provides temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or nasal congestion. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00860014485244	GS1		3	In Commercial Distribution
Primary	00860014485237	GS1