AccessGUDID - DEVICE: COMPUTERIZED VISION TESTER (06971821401021)

GUDID

Device Identifier (DI) Information

Brand Name: COMPUTERIZED VISION TESTER
Version or Model: CV-7600
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ningbo Ming Sing Optical R & D Co., Ltd.

Primary DI Number: 06971821401021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 654386890 *Terms of Use

Device Description: The product is used for subjectively checking eye sight ,and provide diagnosis for ophthalmologist It belongs to non-invasive device,and it may be contacted on patient’s face for short time about several minutes. Just a single dial enabling every operation. Ergonomic switch sheet layout. Easy touch buttons for blind operation. The contents of chart display to be confirmed even in examination in the dark room. The CV-7600 is a computerized autophoropter,including a phoropter head, a controller and a power adapter.

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.	Obsolete	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: dcf91646-712b-4ba4-8790-12b8277958e8
Public Version Date: December 21, 2020
Public Version Number: 2
DI Record Publish Date: December 02, 2019