Nox T3® Demo Recorder 561119

GUDID 15694311110927

Nox Medical ehf.

Polysomnograph

• Primary Device ID: 15694311110927
• NIH Device Record Key: ebeb24fa-a40c-47e8-8949-3a7c0c17f93b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nox T3® Demo Recorder
• Version Model Number: NOX-ASDB1USD
• Catalog Number: 561119
• 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: 999-999-9999
• Email: support@noxmedical.com
• Phone: 999-999-9999
• Email: support@noxmedical.com
• Phone: 999-999-9999
• Email: support@noxmedical.com
• Phone: 999-999-9999
• Email: support@noxmedical.com
• Phone: 999-999-9999
• Email: support@noxmedical.com
• Phone: 999-999-9999
• Email: support@noxmedical.com
• Phone: 999-999-9999
• Email: support@noxmedical.com
• Phone: 999-999-9999
• Email: support@noxmedical.com
• Phone: 999-999-9999
• Email: support@noxmedical.com
• Phone: 999-999-9999
• Email: support@noxmedical.com
• Phone: 999-999-9999
• Email: support@noxmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15694311110927 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

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• 15694311111597 - Nox C1s Kit: 2021-07-19
• 15694311111467 - Nox T3s System: 2021-06-08
• 15694311110682 - Nox A1 Starter Sensor Kit, Adult: 2021-02-11