FDA UDI
In Commercial Distribution
🇺🇸 United States
iScreen Vision
DI: 00864218000104
·
Model: iScreen Vision Screener 3000
·
ISCREEN VISION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iScreen Vision
- Primary DI
- 00864218000104
- Version / Model
- iScreen Vision Screener 3000
- Company Name
- ISCREEN VISION, INC.
- Labeler DUNS
- 035304046
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 578c673b-8a53-4f09-9f11-06f794ee6dbf
Device Description
The iScreen Vision Screener 3000 is a vision screening tool intended to capture and record red reflex images which contain information on ocular status to aid in eye examination. The iScreen Vision Screener 3000 is intended for use solely for a pediatric population by trained professionals.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | Ophthalmic | 886.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61569 | External ocular measurement camera | A hand-held, battery-powered, optical device intended for digital image capture and analysis of the external ocular anatomy to assist in the diagnosis of ophthalmic abnormalities (e.g., ptosis, strabismus, glaucoma); it is not intended to capture images of the fundus. It consists of a digital camera which includes software intended to take specific ocular measurements (e.g., pupil diameter, horizontal visible iris diameter, margin reflex difference, interpupillary distance, strabismus angle). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00864218000104 | GS1 |
Customer Contacts
- Phone
- 901-201-6132
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102651 | 000 |