NL-2-DEM

Basic Information

• Brand Name: NL-2-DEM
• Primary DI: 03665023000627
• Version / Model: NL-2-DEM
• Catalog Number: NL-2-DEM
• Company Name: IDMED
• Labeler DUNS: 260233256
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-10
• Public Version: 1
• Public Version Date: 2022-06-21
• Public Version Status: New
• Public Device Record Key: bd39ea2e-bf72-432a-b48e-e60e2247ffe2

Device Description

NeuroLight kit for demonstration (NeuroLight portable pupillometer NL-MU, wireless charging station STA-W2, 10 eyecups EMB-NL, power supply PWR5-1_US, user manual and robust demonstration case)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
HLG	Pupillometer, Ac-Powered	Ophthalmic	886.1700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13235	Pupillograph	A mains electricity (AC-powered) graphic recorder used for recording the response of the pupil to reflected light. It is used for ophthalmic diagnostic purposes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03665023000627	GS1