Somryst 651010

GUDID 15694311112112

Nox Medical ehf.

Mental health/function therapeutic software, screen-viewed

• Primary Device ID: 15694311112112
• NIH Device Record Key: 10a9bd02-c46f-4ecc-b52d-2f1f7c25f42b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Somryst
• Version Model Number: SOMRYST
• Catalog Number: 651010
• Company DUNS: 365741462
• Company Name: Nox Medical ehf.
• 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: false
• Manufacturing Date: false
• 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	15694311112112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191716

FDA Product Code

• QVO: Computerized Behavioral Therapy Device For Insomnia

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: 2025-01-07
• Device Publish Date: 2024-12-30

Devices Manufactured by Nox Medical ehf.

• 15694311112112 - Somryst: 2025-01-07
• 15694311112112 - Somryst: 2025-01-07
• 15694311111665 - Noxturnal US APP: 2021-10-26
• 15694311111610 - Nox A1® EEG 5 Lead Gold Electrode Cable: 2021-09-15
• 15694311111627 - Nox A1® EEG Head Cable: 2021-09-15
• 15694311111566 - Nox A1s Recorder: 2021-07-19
• 15694311111580 - Nox A1s System: 2021-07-19
• 15694311111597 - Nox C1s Kit: 2021-07-19
• 15694311111467 - Nox T3s System: 2021-06-08