FDA.reportPublic FDA data

Breathewave

Primary DI
00860014485206
Brand
Breathewave
Company
BREATHEWAVE TECHNOLOGIES INC.
Model
Starter Pack
Device description
Contoured Nasal Dilator - Starter Pack - 1x S,M,L
Published
2025-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWFDilator, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWFDilator, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014485206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014485206008600144852068600144852060860014485206

GMDN Terms#

Term, Definition table
TermDefinition
Nasal breathing aid, internal, reusableAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2019407668more@breathewave.com

Regulatory Flags#

DUNS number
138492599
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014485213BreathewaveSmall2025-12-23
00860014485237BreathewaveMedium2025-12-23
00860014485220BreathewaveSmall2025-12-23
00860014485244BreathewaveMedium2025-12-23
00860014485268BreathewaveLarge2025-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850040983111WoodyKnowsM&M Pure Air Systems LLCLWF2026-05-19
00850040983128WoodyKnowsM&M Pure Air Systems LLCLWF2026-05-19
00850040983135WoodyKnowsM&M Pure Air Systems LLCLWF2026-05-19
00850040983142WoodyKnowsM&M Pure Air Systems LLCLWF2026-05-19
00833224009005ZValvesProject SnoreLWF2026-02-20
00833224009012ZValvesProject SnoreLWF2026-02-20
00833224009029ZValvesProject SnoreLWF2026-02-20
00833224009036ZValvesProject SnoreLWF2026-02-20
00833224009043ZValvesProject SnoreLWF2026-02-20
00833224009050ZValvesProject SnoreLWF2026-02-20
00833224009111ZValvesProject SnoreLWF2026-02-20
00833224009128ZValvesProject SnoreLWF2026-02-20
00833224009135ZValvesProject SnoreLWF2026-02-20
00833224009142ZValvesProject SnoreLWF2026-02-20
00833224009159ZValvesProject SnoreLWF2026-02-20
00860014485213BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
00860014485237BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
00860014485220BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
00860014485244BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
00860014485268BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
04719878321525iNAPSOMNICS, INC.LWF2024-02-05
04719878321532iNAPSOMNICS, INC.LWF2024-02-05
00810002220210OASYS (Oral/Nasal Airway System)JOHN'S DENTAL LABORATORY INCLWF2023-03-28
04719878321082SomnicsSOMNICS, INC.LWF2023-03-06
04719878321044SomnicsSOMNICS, INC.LWF2023-02-12
04719878320832SomnicsSOMNICS, INC.LWF2022-11-23
04719878320849SomnicsSOMNICS, INC.LWF2022-11-23
06970757000025YUANRUNBENCAOHebei Yuanrun Medical Devices Co., Ltd.LWF2022-11-01
00033732023016AirmaxMcKeon Products, Inc.LWF2022-10-07
00033732023023AirmaxMcKeon Products, Inc.LWF2022-10-07