Nox A1 Starter Sensor Kit, Adult 558410

GUDID 15694311110682

Nox Medical ehf.

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

• Primary Device ID: 15694311110682
• NIH Device Record Key: 56f39d69-3ffd-4c29-acc4-eacff919c7a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nox A1 Starter Sensor Kit, Adult
• Version Model Number: NOX-A1_SENSKIT1
• Catalog Number: 558410
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	15694311110682 [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

Devices Manufactured by Nox Medical ehf.

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