Nox C1 Access Point

GUDID 15694311111498

Nox Medical ehf.

Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph

• Primary Device ID: 15694311111498
• NIH Device Record Key: a45ee3fa-2a5c-4db7-ac6b-ca81943741fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nox C1 Access Point
• Version Model Number: NOX-SCOM1US
• Company DUNS: 365741462
• Company Name: Nox Medical ehf.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com
• Phone: 9999999999
• Email: support@noxmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15694311111498 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192469

FDA Product Code

• OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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: 2021-02-11
• Device Publish Date: 2021-02-03

On-Brand Devices [Nox C1 Access Point]

• 15694311110590: NOX-SCOM1
• 15694311111498: NOX-SCOM1US