AccessGUDID - DEVICE: MOPTIM (06972039971641)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 06972039971641
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 526992561 *Terms of Use

Device Description: The DEA is intended to do the exams related to the analysis and possible diagnosis of Dry Eye Disease(DED) through the connection of the device to you pc, and particularly. • Interferometry: records a video to the patient’s eye to analyze quantitatively and qualitatively lipid layer of the tear film, to compare it with the related grading scale and save the value; • Tear Meniscus Hight: The tear secretion of the lacrimal layer was assessed by measuring the height of the tear meniscus; • NIBUT: recording a video, it allows to evaluate the stability of the tear film between the break up time in a non-invasive way and to save the value; • Fluorescein BUT: records a video for the evaluation of the tear film’s stability, but it is done with instillation of the fluorescein in the patient’s eye (invasive) and without cone; • Meibography: takes a picture of meibomian glands using infrared light. The device can analyze automatically the loss area of the glands to compare it with the related grading scale; • Additional exams: checks for Bulbar Redness, Blepharitis, Demodex, pupillometry. All the exams that can be performed with the DEA are of fundamental importance for the ophthalmologist and the optometrist (within their respective professional skins) to study the tear film and for coaching the exams done with the classic instruments (Slit Lamp, Topography, Tonometry, etc.).

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?
62593	Meibomian gland camera/ophthalmic interferometer	A mains electricity (AC-powered) multi-purpose optical device intended for: 1) infrared (IR) image capture of the meibomian glands for evaluation of structural abnormalities of the meibomian glands; 2) measurement of the tear film lipid layer using white light image/video capture interferometry; and 3) image capture of the external ocular anatomy. It includes patient head/chin supports, an IR source(s), appropriate cameras, controls and software intended to allow analysis of the images/video and interferometry; it may include an eyelid everter to assist imaging of the meibomian glands.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLR	Keratoscope, Battery-Powered

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
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
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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a3bc689f-2a3e-4878-b40b-8ebdede82e67
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022