Home GUDID 00850022853036 ProSomnus RPMO2 OSA Device
Primary DI 00850022853036
Brand ProSomnus RPMO2 OSA Device
Company PROSOMNUS SLEEP TECHNOLOGIES
Model RPMO2 OSA
Device description An intraoral OSA device with an embedded oximeter used for remote physiologic monitoring.
Published 2026-04-24
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name DQA Oximeter LQZ Device, Jaw Repositioning LRK Device, Anti-Snoring OUG Medical Device Data System PLC Sleep Appliances With Patient Monitoring
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQA Oximeter Cardiovascular 2 LQZ Device, Jaw Repositioning Dental 2 LRK Device, Anti-Snoring Dental 2 OUG Medical Device Data System General Hospital 1 PLC Sleep Appliances With Patient Monitoring Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850022853036 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850022853036 00850022853036 850022853036 0850022853036
GMDN Terms# Term, Definition table Term Definition Mandible-repositioning sleep-disordered breathing orthosis A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.
Regulatory Flags# DUNS number 075438768 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850022853050 ProSomnus Charging Station Charging Station 2026-04-24 00850022853067 ProSomnus HWO2 Device HWO2 2026-04-24 00850022853012 ProSomnus EVO [PH] Sleep and Snore Device EVO [PH] 2024-03-29 00850022853029 ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring EVO [PH] with Patient Monitoring 2024-03-29 00863039000485 ProSomnus EVO Sleep and Snore Device EVO 2024-03-29 00863039000492 ProSomnus EVO Sleep and Snore Device with Patient Monitoring EVO with Patient Monitoring 2024-03-29 00863039000409 Prosomnus CA Sleep and Snore Device CA 2017-12-06 00863039000416 Prosomnus IA Monogram IA Monogram 2017-06-21 00863039000423 Prosomnus IA MicrO2 MicrO2 2017-06-21 00863039000430 Prosomnus IA with Patient Monitoring IA Monogram Monitor 2017-06-21 00863039000454 Prosomnus CA Sleep and Snore Device with Patient Monitoring CA Monitor 2017-12-06 00863039000447 Prosomnus IA MicrO2 with Patient Monitoring MicrO2 with Monitoring 2017-06-21
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