FDA.reportPublic FDA data

Somnics

Primary DI
04719878320849
Brand
Somnics
Company
SOMNICS, INC.
Model
ZeeBud Plus
Device description
ZeeBud Plus Nasal Dilator (M1)
Published
2022-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
04719878320849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719878320849047198783208494719878320849

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
1-833-766-6427service.us@somnics.com

Regulatory Flags#

DUNS number
657169335
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719878320122iNAPR07-A11000-7A2024-02-05
04719878321099iNAP One Starter Kit2023-03-07
04719878321105iNAP One Starter Kit2023-03-07
04719878321075iNAP One Quarterly Kit2023-03-06
04719878320108iNAP One P0126000-012022-06-15
04719878320528iNAP One Quarterly Set w/I0791010-942022-06-15
04719878320535iNAP One Quarterly Set w/I07H91010-9H2022-06-15
04719878320542iNAP One Quarterly Set w/I07S91010-9S2022-06-15
04719878320023iNAPR07-B11000-072022-06-01
04719878320061iNAPI02C24000-2C2022-06-01
04719878320559iNAPA032022-06-01
04719878320887iNAP One Quarterly Kit2022-06-01
04719878320511iNAP28001-0728001-072021-07-21
04719878320184iNAP81000-0781000-072021-07-13
04719878320252iNAP24000-7H24000-7H2021-06-03
04719878320047iNAP24000-7S24000-7S2020-12-23
04719878320009iNAP91000-0791000-072020-09-23
04719878320030iNAP24000-0724000-072020-09-23
04719878320078iNAP23000-0123000-012020-09-23
04719878320092iNAP21000-0321000-032020-09-23

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
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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
00860014485213BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
00860014485237BreathewaveBREATHEWAVE TECHNOLOGIES INC.LWF2025-12-23
00860014485206BreathewaveBREATHEWAVE 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
06970757000025YUANRUNBENCAOHebei Yuanrun Medical Devices Co., Ltd.LWF2022-11-01
00033732023016AirmaxMcKeon Products, Inc.LWF2022-10-07
00033732023023AirmaxMcKeon Products, Inc.LWF2022-10-07