FDA.reportPublic FDA data

Prosomnus IA MicrO2 with Patient Monitoring

Primary DI
00863039000447
Brand
Prosomnus IA MicrO2 with Patient Monitoring
Company
PROSOMNUS SLEEP TECHNOLOGIES
Model
MicrO2 with Monitoring
Device description
Obstructive Sleep Apnea Device with twin mated posts and Patient Monitoring
Published
2017-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PLCSleep Appliances With Patient Monitoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLCSleep Appliances With Patient MonitoringDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863039000447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863039000447008630390004478630390004470863039000447

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
075438768
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022853036ProSomnus RPMO2 OSA DeviceRPMO2 OSA2026-04-24
00850022853050ProSomnus Charging StationCharging Station2026-04-24
00850022853067ProSomnus HWO2 DeviceHWO22026-04-24
00850022853012ProSomnus EVO [PH] Sleep and Snore DeviceEVO [PH]2024-03-29
00850022853029ProSomnus EVO [PH] Sleep and Snore Device with Patient MonitoringEVO [PH] with Patient Monitoring 2024-03-29
00863039000485ProSomnus EVO Sleep and Snore DeviceEVO2024-03-29
00863039000492ProSomnus EVO Sleep and Snore Device with Patient MonitoringEVO with Patient Monitoring 2024-03-29
00863039000409Prosomnus CA Sleep and Snore DeviceCA 2017-12-06
00863039000416Prosomnus IA MonogramIA Monogram2017-06-21
00863039000423Prosomnus IA MicrO2MicrO22017-06-21
00863039000430Prosomnus IA with Patient MonitoringIA Monogram Monitor2017-06-21
00863039000454Prosomnus CA Sleep and Snore Device with Patient MonitoringCA Monitor2017-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESPLC2026-04-24
00863039000454Prosomnus CA Sleep and Snore Device with Patient MonitoringPROSOMNUS SLEEP TECHNOLOGIESPLC2017-12-06
00851861007222Respire Pink+ Hard with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-09-15
00851861007246Respire Pink EF+ with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-09-15
00851861007161Respire Pink Series with DentiTrac - HRESPIRE MEDICAL HOLDINGS LLCPLC2017-07-14
00851861007178Respire Pink Series H/S with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-07-14
00851861007185Respire Pink Series EF with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-07-14
00851861007192Respire Pink Series Micro with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-07-14
00851861007208Respire Pink Series Micro H/S with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-07-14
00851861007215Respire Pink Series EF Micro with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-07-14
00863039000430Prosomnus IA with Patient MonitoringPROSOMNUS SLEEP TECHNOLOGIESPLC2017-06-21
00851861007239Respire Pink+ H/S with DentiTracRESPIRE MEDICAL HOLDINGS LLCPLC2017-06-19