ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring

GUDID 00850022853029

PROSOMNUS SLEEP TECHNOLOGIES

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00850022853029
• NIH Device Record Key: 646e0256-73d7-42f9-b3b4-f08d68bb2850
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
• Version Model Number: EVO [PH] with Patient Monitoring
• 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: false
• 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	00850022853029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221889

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-08
• Device Publish Date: 2024-03-29

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
• 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: 2018-07-06 Obstructive Sleep Apnea with Iterative Adjustment and Patient Monitoring