Nox Service Kit, s 569015

GUDID 15694311111405

Nox Medical ehf.

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

• Primary Device ID: 15694311111405
• NIH Device Record Key: 6b03c170-542f-4d91-a748-082c03797252
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nox Service Kit, s
• Version Model Number: NOX-T3S-SERVICEKIT
• Catalog Number: 569015
• 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: 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
• 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	15694311111405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082113

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2020-07-09
• Device Publish Date: 2020-07-01

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