NearBright

Basic Information

• Brand Name: NearBright
• Primary DI: 00812559012003
• Version / Model: 16238
• Company Name: REICHERT, INC.
• Labeler DUNS: 126650253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-12
• Public Version: 1
• Public Version Date: 2025-08-20
• Public Version Status: New
• Public Device Record Key: 9647e40b-4c35-4fc2-b52a-13ad01258934

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: Labeling does not contain MRI Safety Information
• 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
HOX	Chart, Visual Acuity	Ophthalmic	886.1150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16800	Vision testing/training chart	An ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812559012003	GS1