Prosomnus IA with Patient Monitoring

GUDID 00863039000430

Obstructive Sleep Apnea with Iterative Adjustment and Patient Monitoring

PROSOMNUS SLEEP TECHNOLOGIES

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00863039000430
• NIH Device Record Key: 10c906f3-85ac-443f-b0f1-8f7f8516444c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prosomnus IA with Patient Monitoring
• Version Model Number: IA Monogram Monitor
• Company DUNS: 075438768
• Company Name: PROSOMNUS SLEEP TECHNOLOGIES
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863039000430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161624

FDA Product Code

• PLC: Sleep Appliances With Patient Monitoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-21

Devices Manufactured by PROSOMNUS SLEEP TECHNOLOGIES

• 00850022853012 - ProSomnus EVO [PH] Sleep and Snore Device: 2024-04-08
• 00850022853029 - ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring: 2024-04-08
• 00863039000485 - ProSomnus EVO Sleep and Snore Device: 2024-04-08
• 00863039000492 - ProSomnus EVO Sleep and Snore Device with Patient Monitoring: 2024-04-08
• 00863039000409 - Prosomnus CA Sleep and Snore Device: 2018-07-06
• 00863039000416 - Prosomnus IA Monogram: 2018-07-06 Device for Obstructive Sleep Apnea iterative adjustment with patient comfort features
• 00863039000423 - Prosomnus IA MicrO2: 2018-07-06 Obstructive Sleep Apnea Device with twin mated posts
• 00863039000430 - Prosomnus IA with Patient Monitoring: 2018-07-06Obstructive Sleep Apnea with Iterative Adjustment and Patient Monitoring
• 00863039000430 - Prosomnus IA with Patient Monitoring: 2018-07-06 Obstructive Sleep Apnea with Iterative Adjustment and Patient Monitoring