AccessGUDID - DEVICE: Computerized vision tester (06971821401038)

GUDID

Device Identifier (DI) Information

Brand Name: Computerized vision tester
Version or Model: CV-7800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ningbo Ming Sing Optical R & D Co., Ltd.

Primary DI Number: 06971821401038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 654386890 *Terms of Use

Device Description: The new Intellectual interaction mode The new CV-7800 auto phoropter has made great improvement in human and machine interaction compared to last generation. It supports both tablet and control panel control, making the operation more flexible for more outstanding refraction.More efficient and faster control and operation 1.Quieter and all-round Thanks to the brand new mechnicial design and imported motors, the Tianle CV-7800 auto phoropter not only make less noise for lens switch, but also provide more outstanding refraction result, providing our user with less annoying noise and more plsasant using experience. 2.Excellent apperance & performance With a new look dsiplays sense of technology and faster lens switch speed and longer working lfie, the new CV-7800 is refined both internally and externally. 3.Customized refraction process The strong intellectual interaction mode supports uyser to customize refraction process according to their own habit. Multiple control method makes all the operation more intelligent and efficient.

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):	Yes
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?
35299	Phoropter	An ophthalmic device intended to be placed in front of a patient's eyes to measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an ophthalmic examination, typically to determine a patient's prescription for glasses. It typically consists of two mounted, disk-like housings which contain lenses of different characteristics. It is designed such that the optometrist can change the lenses and other settings while asking the patient to read an eye chart and to provide subjective feedback on which settings give best vision. The setting changes may be manual or automated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIT	Tester, Color Vision

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53deb296-a702-4f4f-bc2b-189960b3032b
Public Version Date: December 21, 2020
Public Version Number: 2
DI Record Publish Date: August 20, 2020