AccessGUDID - DEVICE: MOPTIM (06972039971542)

GUDID

Device Identifier (DI) Information

Brand Name: MOPTIM
Version or Model: iRef
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen CERTAINN Technology Co., Ltd.

Primary DI Number: 06972039971542
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 526992561 *Terms of Use

Device Description: The manual refractometer is composed of a lens and a removable eye chart. The testee is required to move the position of the eye chart after resetting to make the visual target become clearer from blur. Once the clearest position of the visual target is determined, the testee’s estimated refractive error can be read from the display screen of the instrument.

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?
65244	Hand-held subjective ophthalmic refractometer	A hand-held ophthalmic device intended to be used by a layperson to measure the refractive error of their eye (the inaccuracies of focusing light upon the retina), typically to test their vision. It is typically in the form of a monocular which contains lenses of different characteristics; a dedicated software providing examination protocols may also be included. The patient changes the lenses and other settings while reading an eye chart to subjectively evaluate which settings give best vision.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKO	Refractometer, Ophthalmic

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 Temperature: between 5 and 40 Degrees Celsius
Handling Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 86 and 106 KiloPascal
Storage Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 86 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 739e0e61-6e70-4c41-a598-5869b8edd7a0
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022