AccessGUDID - DEVICE: Remidio (08906096520014)

GUDID

Device Identifier (DI) Information

Brand Name: Remidio
Version or Model: 001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED

Primary DI Number: 08906096520014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 650711448 *Terms of Use

Device Description: FOP NM-10 is indicated for screening, capture and storage of images of the eye and surrounding area, FOP NM 10 camera is been designed for true colour and monochrome imaging in visible spectrum of light and consists of an incoherent light source. Light from the device is shown into the patient eye & the camera of a smart phone is used to capture images of the eye.

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:	Yes
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?
10551	Ophthalmic fundus camera	An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.	Active	false
62635	Smartphone camera ophthalmic imaging lens	An optical device intended to be attached over the camera lens of an off-the-shelf smartphone by a healthcare professional to enable imaging of the eye, including anterior segment and/or fundus, using the existing camera/video capabilities of the smartphone. It includes a lens and a smartphone-attachable portion, and may be intended for use with dedicated software (app). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJZ	Camera, Ophthalmic, General-Use

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 Temperature: 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: 4f1fd8ea-bc08-4f7c-8467-b9f8e16d443c
Public Version Date: July 14, 2023
Public Version Number: 6
DI Record Publish Date: February 03, 2019