Nox A1® EEG Head Cable 561112

GUDID 15694311111627

Nox Medical ehf.

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• Primary Device ID: 15694311111627
• NIH Device Record Key: aaff874d-dd3d-4391-a00b-2d2059a74c30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nox A1® EEG Head Cable
• Version Model Number: APSGH1PAC1US
• Catalog Number: 561112
• 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: true
• Serial Number: false
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	15694311111627 [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: 2021-09-15
• Device Publish Date: 2021-09-07

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• 15694311111627 - Nox A1® EEG Head Cable: 2021-09-15
• 15694311111627 - Nox A1® EEG Head Cable: 2021-09-15
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• 15694311111597 - Nox C1s Kit: 2021-07-19
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• 15694311110682 - Nox A1 Starter Sensor Kit, Adult: 2021-02-11