Nox A1 System 513510

GUDID 15694311111375

Nox Medical ehf.

Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser

• Primary Device ID: 15694311111375
• NIH Device Record Key: df34bae2-2c38-41c3-8279-11381d0e7fa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nox A1 System
• Version Model Number: NOX-A1PSG_USF
• Catalog Number: 513510
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15694311111375 [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: 2020-03-03
• Device Publish Date: 2020-02-24

Devices Manufactured by Nox Medical ehf.

• 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
• 15694311110682 - Nox A1 Starter Sensor Kit, Adult: 2021-02-11