Remidio

Basic Information

• Brand Name: Remidio
• Primary DI: 08906096520021
• Version / Model: AIM
• Catalog Number: 3231680012
• Company Name: REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
• Labeler DUNS: 650711448
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-19
• Public Version: 4
• Public Version Date: 2023-07-14
• Public Version Status: Update
• Public Device Record Key: 8b0cfcf0-7f30-4c56-acd9-a0a858ee726b

Device Description

Anterior Imaging Module (AIM) is intended for screening, capture and storage of images of the Anterior part of eye and surrounding area, AIM camera is designed to be attached to any existing 3 step or 5 step slit lamps for true colour and monochrome imaging in visible spectrum of light. The camera of a smart phone is used to capture images of the eye. The device can be used at any time & over & over again by a trained user.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PJZ	Camera, Ophthalmic, General-Use	Ophthalmic	886.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08906096520021	GS1

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius