AccessGUDID - DEVICE: Visual Chart System (08800074500114)

GUDID

Device Identifier (DI) Information

Brand Name: Visual Chart System
Version or Model: CSPOLA600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CSPOLA600
Company Name: VIEW-M TECHNOLOGY CO., LTD.

Primary DI Number: 08800074500114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557821283 *Terms of Use

Device Description: CSPOLA600 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOX	Chart, Visual Acuity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5439a5a-3573-4121-b97c-bbdecb40b298
Public Version Date: April 02, 2024
Public Version Number: 1
DI Record Publish Date: March 25, 2024