FDA.reportPublic FDA data

Airmax

Primary DI
00033732023016
Brand
Airmax
Company
McKeon Products, Inc.
Model
Nasal Dilator - Small - Blue
Catalog number
2301
Published
2022-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00033732023016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00033732023016000337320230160337320230160033732023016

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

Regulatory Flags#

DUNS number
006522122
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00033732000789Mack'sPillow Soft Silicone Putty Earplugs7T2025-08-05
00033732007122Mack'sPillow Soft Silicone Putty Earplugs7122025-08-05
00033732007184Mack'sPillow Soft Silicone Putty Earplugs7182025-08-05
00033732100786Mack'sPillow Soft Silicone Putty Earplugs7T2025-08-05
00033732107129Mack'sPillow Soft Silicone Putty Earplugs7122025-08-05
00033732107181Mack'sPillow Soft Silicone Putty Earplugs7182025-08-05
00033732000055Mack'sPillow Soft Silicone Putty Earplugs52022-10-07
00033732000062Mack'sPillow Soft Silicone Putty Earplugs (Orange)62022-10-07
00033732000086Mack'sPillow Soft Silicone Putty Earplugs (Beige)82022-10-07
00033732000109Mack'sKids Size Soft Moldable Silicone Putty Earplugs102022-10-07
00033732002004Mack'sPillow Soft Silicone Putty Earplug Dispenser2002022-10-07
00033732002066Mack'sPillow Soft Silicone Putty Earplug Dispenser (Oran2062022-10-07
00033732002080Mack'sPillow Soft Silicone Putty Earplug Dispenser (Beig2082022-10-07
00033732002103Mack'sKids Size Moldable Silicone Putty Earplug Dispense2102022-10-07
00033732010153Mack'sKids Size Soft Moldable Silicone Putty Earplugs10152022-10-07
10033732000052Mack'sPillow Soft Silicone Putty Earplugs52022-10-07
10033732000069Mack'sPillow Soft Silicone Putty Earplugs (Orange)62022-10-07
00033732000079Mack'sPillow Soft Silicone Putty Earplugs72022-10-07
10033732000083Mack'sPillow Soft Silicone Putty Earplugs (Beige)82022-10-07
10033732000106Mack'sKids Size Soft Moldable Silicone Putty Earplugs102022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
00033732023023AirmaxMcKeon Products, Inc.LWF2022-10-07