Nox A1® EEG 5 Lead Gold Electrode Cable

Basic Information

• Brand Name: Nox A1® EEG 5 Lead Gold Electrode Cable
• Primary DI: 15694311111610
• Version / Model: ECUP5AU1PAC1US
• Catalog Number: 554412
• Company Name: Nox Medical ehf.
• Labeler DUNS: 365741462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-07
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 90df20d2-49ef-4a8b-bd41-7ea2028744bf

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	882.1400	2
KZM	Device, Muscle Monitoring	Physical Medicine	890.1375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47713	Analytical scalp electrode, reusable	A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk/star with a conductive surface (e.g., tin, gold, silver, titanium, conductive plastic) and may include a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15694311111610	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K192469	000