AccessGUDID - DEVICE: Remidio (08906096520045)

GUDID

Device Identifier (DI) Information

Brand Name: Remidio
Version or Model: PSL - D20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3231680018
Company Name: REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED

Primary DI Number: 08906096520045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 650711448 *Terms of Use

Device Description: Remidio Portable Slit Lamp (PSL-D20) is a handheld digital device for anterior segment screening & diagnosis of the human eye. High-resolution images obtained with advanced optics and using iPhone’s latest technology. User-friendly iOS enhances the imaging technology and the Remidio patient management application enable the user to view, save, archive, edit and retrieve the captured Anterior Images using a built im-age archival database.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
35148	Ophthalmic examination slit lamp	An electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJO	Biomicroscope, Slit-Lamp, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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 Atmospheric Pressure: between -10 and 55 Degrees Celsius
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 03e60122-09d2-4725-b38c-0834adb490d9
Public Version Date: July 14, 2023
Public Version Number: 4
DI Record Publish Date: November 26, 2021