Home GUDID 04719878321587 iNAP
Primary DI 04719878321587
Brand iNAP
Company SOMNICS, INC.
Model Starter Kit (Serviced)
Device description (1) iNAP One Sleep Therapy System [iNAP Console(R07-A) x1, Tubing Set x1, Saliva Container x1, Power Adapter x1, Oral Interface (Model: I07H) x1, DryPad x93]; (2) Nasal Dilator [ZEEBUD x1]
Published 2026-09-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LWF Dilator, Nasal OZR Intraoral Pressure Gradient Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LWF Dilator, Nasal Ear, Nose, Throat 1 OZR Intraoral Pressure Gradient Device Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04719878321587 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04719878321587 04719878321587 4719878321587
GMDN Terms# Term, Definition table Term Definition Intraoral negative-pressure sleep apnoea unit An 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.
Regulatory Flags# DUNS number 657169335 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04719878321570 iNAP SOMNICS, INC. OZR 2026-09-21 00850040983111 WoodyKnows M&M Pure Air Systems LLC LWF 2026-05-19 00850040983128 WoodyKnows M&M Pure Air Systems LLC LWF 2026-05-19 00850040983135 WoodyKnows M&M Pure Air Systems LLC LWF 2026-05-19 00850040983142 WoodyKnows M&M Pure Air Systems LLC LWF 2026-05-19 00833224009005 ZValves Project Snore LWF 2026-02-20 00833224009012 ZValves Project Snore LWF 2026-02-20 00833224009029 ZValves Project Snore LWF 2026-02-20 00833224009036 ZValves Project Snore LWF 2026-02-20 00833224009043 ZValves Project Snore LWF 2026-02-20 00833224009050 ZValves Project Snore LWF 2026-02-20 00833224009111 ZValves Project Snore LWF 2026-02-20 00833224009128 ZValves Project Snore LWF 2026-02-20 00833224009135 ZValves Project Snore LWF 2026-02-20 00833224009142 ZValves Project Snore LWF 2026-02-20 00833224009159 ZValves Project Snore LWF 2026-02-20 00860014485213 Breathewave BREATHEWAVE TECHNOLOGIES INC. LWF 2025-12-23 00860014485237 Breathewave BREATHEWAVE TECHNOLOGIES INC. LWF 2025-12-23 00860014485206 Breathewave BREATHEWAVE TECHNOLOGIES INC. LWF 2025-12-23 00860014485220 Breathewave BREATHEWAVE TECHNOLOGIES INC. LWF 2025-12-23 00860014485244 Breathewave BREATHEWAVE TECHNOLOGIES INC. LWF 2025-12-23 00860014485268 Breathewave BREATHEWAVE TECHNOLOGIES INC. LWF 2025-12-23 04719878320122 iNAP SOMNICS, INC. OZR 2024-02-05 04719878321525 iNAP SOMNICS, INC. OZR 2024-02-05 04719878321525 iNAP SOMNICS, INC. LWF 2024-02-05 04719878321532 iNAP SOMNICS, INC. OZR 2024-02-05 04719878321532 iNAP SOMNICS, INC. LWF 2024-02-05 00810002220210 OASYS (Oral/Nasal Airway System) JOHN'S DENTAL LABORATORY INC LWF 2023-03-28 04719878321099 iNAP One SOMNICS, INC. OZR 2023-03-07 04719878321105 iNAP One SOMNICS, INC. OZR 2023-03-07
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