Prosomnus IA Monogram

GUDID 00863039000416

Device for Obstructive Sleep Apnea iterative adjustment with patient comfort features

PROSOMNUS SLEEP TECHNOLOGIES

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device ID00863039000416
NIH Device Record Keybcfcde1c-8ef5-45a3-9ea1-f62f947718c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameProsomnus IA Monogram
Version Model NumberIA Monogram
Company DUNS075438768
Company NamePROSOMNUS SLEEP TECHNOLOGIES
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100863039000416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-06-21

Devices Manufactured by PROSOMNUS SLEEP TECHNOLOGIES

00850022853012 - ProSomnus EVO [PH] Sleep and Snore Device2024-04-08
00850022853029 - ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring2024-04-08
00863039000485 - ProSomnus EVO Sleep and Snore Device2024-04-08
00863039000492 - ProSomnus EVO Sleep and Snore Device with Patient Monitoring2024-04-08
00863039000409 - Prosomnus CA Sleep and Snore Device2018-07-06
00863039000416 - Prosomnus IA Monogram2018-07-06Device for Obstructive Sleep Apnea iterative adjustment with patient comfort features
00863039000416 - Prosomnus IA Monogram2018-07-06 Device for Obstructive Sleep Apnea iterative adjustment with patient comfort features
00863039000423 - Prosomnus IA MicrO22018-07-06 Obstructive Sleep Apnea Device with twin mated posts
00863039000430 - Prosomnus IA with Patient Monitoring2018-07-06 Obstructive Sleep Apnea with Iterative Adjustment and Patient Monitoring

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