Home GUDID 04719878321570 iNAP
Primary DI 04719878321570
Brand iNAP
Company SOMNICS, INC.
Model R07-A
Catalog number 11000-7A
Device description iNAP One Sleep Therapy System Console (Serviced)
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 OZR Intraoral Pressure Gradient Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OZR Intraoral Pressure Gradient Device Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04719878321570 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04719878321570 04719878321570 4719878321570
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 false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 04719878321587 iNAP SOMNICS, INC. OZR 2026-09-21 04719878320122 iNAP SOMNICS, INC. OZR 2024-02-05 04719878321525 iNAP SOMNICS, INC. OZR 2024-02-05 04719878321532 iNAP SOMNICS, INC. OZR 2024-02-05 04719878321099 iNAP One SOMNICS, INC. OZR 2023-03-07 04719878321105 iNAP One SOMNICS, INC. OZR 2023-03-07 04719878321075 iNAP One SOMNICS, INC. OZR 2023-03-06 04719878320856 Somnics SOMNICS, INC. OZR 2022-11-28 04719878320108 iNAP One SOMNICS, INC. OZR 2022-06-15 04719878320528 iNAP One SOMNICS, INC. OZR 2022-06-15 04719878320535 iNAP One SOMNICS, INC. OZR 2022-06-15 04719878320542 iNAP One SOMNICS, INC. OZR 2022-06-15 04719878320023 iNAP SOMNICS, INC. OZR 2022-06-01 04719878320061 iNAP SOMNICS, INC. OZR 2022-06-01 04719878320559 iNAP SOMNICS, INC. OZR 2022-06-01 04719878320887 iNAP One SOMNICS, INC. OZR 2022-06-01 04719878320511 iNAP SOMNICS, INC. OZR 2021-07-21 04719878320184 iNAP SOMNICS, INC. OZR 2021-07-13 04719878320252 iNAP SOMNICS, INC. OZR 2021-06-03 04719878320047 iNAP SOMNICS, INC. OZR 2020-12-23 04719878320009 iNAP SOMNICS, INC. OZR 2020-09-23 04719878320030 iNAP SOMNICS, INC. OZR 2020-09-23 04719878320078 iNAP SOMNICS, INC. OZR 2020-09-23 04719878320092 iNAP SOMNICS, INC. OZR 2020-09-23 04719878320115 iNAP SOMNICS, INC. OZR 2020-09-23 00852126007001 Winx® APNICURE, INC. OZR 2016-09-16 00852126007018 Winx® APNICURE, INC. OZR 2016-09-16 00852126007025 Winx® APNICURE, INC. OZR 2016-09-16 00852126007032 Winx® APNICURE, INC. OZR 2016-09-16 00852126007049 Winx® APNICURE, INC. OZR 2016-09-16
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