FDA.reportPublic FDA data

Somnics

Primary DI
04719878320856
Brand
Somnics
Company
SOMNICS, INC.
Model
iBreath
Device description
iBreath Breathing Training Kit
Published
2022-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IODComponents, Exercise
OZRIntraoral Pressure Gradient Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IODComponents, ExercisePhysical Medicine1
OZRIntraoral Pressure Gradient DeviceDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719878320856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719878320856047198783208564719878320856

GMDN Terms#

Term, Definition table
TermDefinition
Tongue/lip exerciserA hand-held mechanical device intended to provide resistance to tongue and/or lip movements for rehabilitation of oral motor function, typically to aid in swallow and speech therapy, following impairment (e.g., dysphagia, dysarthria) from stroke or other neurological conditions. It consists of an intraoral bulb with a connected handle, similar to an infant pacifier in appearance, made of flexible silicone. This is a single-patient, 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
00840314816108"STAIRS,TIMBER,MINI STRAIGHT,2 6""STEPS,3"Hausmann Enterprises, LLCIOD2025-04-14
00840314816122"STAIRS,TIMBER,SINGLE-SIDE,4 6""STEPS"Hausmann Enterprises, LLCIOD2025-04-14
00810113576367ViveVIVE HEALTH LLCIOD2024-08-20
10810113576364ViveVIVE HEALTH LLCIOD2024-08-20
00810113574356ViveVIVE HEALTH LLCIOD2024-07-17
00810113577296ViveVIVE HEALTH LLCIOD2024-07-17
10810113574353ViveVIVE HEALTH LLCIOD2024-07-17
10810113577293ViveVIVE HEALTH LLCIOD2024-07-17
04719878320122iNAPSOMNICS, INC.OZR2024-02-05
04719878321525iNAPSOMNICS, INC.OZR2024-02-05
04719878321532iNAPSOMNICS, INC.OZR2024-02-05
00057475571184BIOS LivingThermor LtdIOD2023-09-18
10057475571181BIOS LivingThermor LtdIOD2023-09-18
00810113573403ViveVIVE HEALTH LLCIOD2023-08-23
10810113573400ViveVIVE HEALTH LLCIOD2023-08-23
00818323029529ViveVIVE HEALTH LLCIOD2023-08-02
00818323029536ViveVIVE HEALTH LLCIOD2023-08-02
10818323029526ViveVIVE HEALTH LLCIOD2023-08-02
10818323029533ViveVIVE HEALTH LLCIOD2023-08-02
G505MRBHS0Balance Harness M.A.S.S. Rehab, LLCIOD2023-08-01
G505MRHSH0Healing Solutions HarnessM.A.S.S. Rehab, LLCIOD2023-08-01
G505MRUHB0Unloading Harness BariatricM.A.S.S. Rehab, LLCIOD2023-08-01
G505MRUHS0Unloading HarnessM.A.S.S. Rehab, LLCIOD2023-08-01
00840252911828Dig-o-meterTherafin CorporationIOD2023-07-06
00810041982353VIVEVIVE HEALTH LLCIOD2023-06-30
10810041982350VIVEVIVE HEALTH LLCIOD2023-06-30
07290019733003HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733836TutorCart WorkStationMEDITOUCH LTDIOD2023-06-21
07290019733843TutorCart WorkStationMEDITOUCH LTDIOD2023-06-21
072900197338503DTutor StationMEDITOUCH LTDIOD2023-06-21