FDA UDI
In Commercial Distribution
🇺🇸 United States
Remidio
DI: 08906096520045
·
Model: PSL - D20
·
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Remidio
- Primary DI
- 08906096520045
- Version / Model
- PSL - D20
- Catalog Number
- 3231680018
- 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
- 2021-11-26
- Public Version
- 4
- Public Version Date
- 2023-07-14
- Public Version Status
- Update
- Public Device Record Key
- 03e60122-09d2-4725-b38c-0834adb490d9
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | Ophthalmic | 886.1850 | 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 | 08906096520045 | GS1 |
Customer Contacts
- Phone
- +917676759999
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity