AccessGUDID - DEVICE: YEASN (06971922132794)

GUDID

Device Identifier (DI) Information

Brand Name: YEASN
Version or Model: MPH150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPH150BP
Company Name: Chongqing Yeasn Science & Technology Co.,Ltd.

Primary DI Number: 06971922132794
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 547954649 *Terms of Use

Device Description: This instrument is intended to be used for performing subjective refraction eye examinations.

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?
66911	Phoropter, manual	A manually-operated ophthalmic device intended to be placed in front of a patient's eyes to assist with measuring the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an examination, typically to determine a patient's prescription for glasses. Also known as a manual refractor, it typically consists of two mounted disk-like housings (head) which contain lenses of different characteristics. The optometrist manually changes the lenses and other settings while asking the patient to read an eye chart and provide subjective feedback on which settings give best vision.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKN	Refractor, Manual, Non-Powered, Including Phoropter

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: 7a2d2ce7-2fe4-4714-8104-187d1c4625fa
Public Version Date: December 09, 2024
Public Version Number: 1
DI Record Publish Date: November 30, 2024