Visual Chart System

Basic Information

• Brand Name: Visual Chart System
• Primary DI: 08800074500046
• Version / Model: SCS-3200
• Catalog Number: SCS-3200
• Company Name: VIEW-M TECHNOLOGY CO., LTD.
• Labeler DUNS: 557821283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-08
• Public Version: 1
• Public Version Date: 2023-03-16
• Public Version Status: New
• Public Device Record Key: a668cd70-9e76-4dfe-ba48-e19a6dbb4aa1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
36380	Visual acuity light box	A mains electricity (AC-powered) light viewing box that uses a translucent version of the ophthalmic chart (Snellen chart) imprinted with block letters (optotypes) and/or other symbols (e.g., LEA symbols for children who can not read) in gradually decreasing sizes used for testing visual acuity. The letters/symbols are identified according to distances at which they are ordinarily visible (normally 6 metres or 20 feet) and are combined in a box where the individual letters or symbols are selected and high-lighted by the optician/doctor with background electrical lighting. This device is typically mounted on a wall of the optician/doctor's examination room/office.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800074500046	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal