Breathewave

GUDID 00860014485244

Contoured Nasal Dilator

BREATHEWAVE TECHNOLOGIES INC.

Nasal breathing aid, internal, reusable

• Primary Device ID: 00860014485244
• NIH Device Record Key: 33c8e110-4410-40a5-a510-022e084a8175
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breathewave
• Version Model Number: Medium
• Company DUNS: 138492599
• Company Name: BREATHEWAVE TECHNOLOGIES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860014485237 [Primary]
GS1	00860014485244 [Package]; Contains: 00860014485237; Package: [3 Units]; In Commercial Distribution

FDA Product Code

• LWF: Dilator, Nasal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-31
• Device Publish Date: 2025-12-23

On-Brand Devices [Breathewave]

• 00860014485268: Contoured Nasal Dilator
• 00860014485244: Contoured Nasal Dilator
• 00860014485220: Contoured Nasal Dilator
• 00860014485206: Contoured Nasal Dilator - Starter Pack - 1x S,M,L