neon8

Basic Information

• Brand Name: neon8
• Primary DI: 05391530950077
• Version / Model: TF04
• Company Name: INCEREB LIMITED
• Labeler DUNS: 985065024
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-16
• Public Version: 2
• Public Version Date: 2022-03-25
• Public Version Status: Update
• Public Device Record Key: 80df5894-6387-475d-ab75-76b425f8aee7

Device Description

EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. The device is single use only. This new DI is a new packaging format. The old number was a tray with a peel off lid. This DI is the "Clamshell" in a pouch packaging

Device Characteristics

• Single Use: Yes
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11440	Analytical scalp electrode, single-use	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 with a conductive surface (e.g., tin, gold, conductive plastic) and 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 single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05391530950084	GS1	box	5	In Commercial Distribution
Primary	05391530950077	GS1
Previous	05391530950039	GS1

Premarket Submissions

Submission Number	Supplement Number
K151576	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 25 Degrees Celsius