FDA.reportPublic FDA data

iNAP One

Primary DI
04719878320887
Brand
iNAP One
Company
SOMNICS, INC.
Model
Quarterly Kit
Device description
iNAP One Quarterly Kit
Published
2022-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZRIntraoral Pressure Gradient Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZRIntraoral Pressure Gradient DeviceDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193460000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193460000The iNAP One Sleep Therapy SystemSomnice, Inc.2020-05-26OZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719878320887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719878320887047198783208874719878320887

GMDN Terms#

Term, Definition table
TermDefinition
Intraoral negative-pressure sleep apnoea unitAn electrically-powered device intended for home management of obstructive sleep apnoea (OSA) by using low, negative air pressure in the mouth to pull the soft palate and tongue forward to increase the patency of the pharynx; this repositioning obstructs oral breathing while allowing nasal breathing. It consists of a control unit containing a pump and sensor(s), to detect and adjust air pressure within the oral cavity, connected to a specially designed mouthpiece; it may in addition include associated items (e.g., saliva container, absorbent pad). 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
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
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
04719878320115iNAP22000-0722000-072020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719878320122iNAPSOMNICS, INC.OZR2024-02-05
04719878321525iNAPSOMNICS, INC.OZR2024-02-05
04719878321532iNAPSOMNICS, INC.OZR2024-02-05
04719878321099iNAP One SOMNICS, INC.OZR2023-03-07
04719878321105iNAP One SOMNICS, INC.OZR2023-03-07
04719878321075iNAP One SOMNICS, INC.OZR2023-03-06
04719878320856SomnicsSOMNICS, INC.OZR2022-11-28
04719878320108iNAP One SOMNICS, INC.OZR2022-06-15
04719878320528iNAP One SOMNICS, INC.OZR2022-06-15
04719878320535iNAP One SOMNICS, INC.OZR2022-06-15
04719878320542iNAP One SOMNICS, INC.OZR2022-06-15
04719878320023iNAPSOMNICS, INC.OZR2022-06-01
04719878320061iNAPSOMNICS, INC.OZR2022-06-01
04719878320559iNAPSOMNICS, INC.OZR2022-06-01
04719878320511iNAPSOMNICS, INC.OZR2021-07-21
04719878320184iNAPSOMNICS, INC.OZR2021-07-13
04719878320252iNAPSOMNICS, INC.OZR2021-06-03
04719878320047iNAPSOMNICS, INC.OZR2020-12-23
04719878320009iNAPSOMNICS, INC.OZR2020-09-23
04719878320030iNAPSOMNICS, INC.OZR2020-09-23
04719878320078iNAPSOMNICS, INC.OZR2020-09-23
04719878320092iNAPSOMNICS, INC.OZR2020-09-23
04719878320115iNAPSOMNICS, INC.OZR2020-09-23
00852126007001Winx®APNICURE, INC.OZR2016-09-16
00852126007018Winx®APNICURE, INC.OZR2016-09-16
00852126007025Winx®APNICURE, INC.OZR2016-09-16
00852126007032Winx®APNICURE, INC.OZR2016-09-16
00852126007049Winx®APNICURE, INC.OZR2016-09-16
00852126007056Winx®APNICURE, INC.OZR2016-09-16
00852126007063Winx®APNICURE, INC.OZR2016-09-16