FDA UDI
In Commercial Distribution
🇺🇸 United States
Foresee Home™
DI: 07290017803005
·
Model: V2
·
NOTAL VISION LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Foresee Home™
- Primary DI
- 07290017803005
- Version / Model
- V2
- Catalog Number
- 901F001
- Company Name
- NOTAL VISION LTD
- Labeler DUNS
- 532596533
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-01
- Public Version
- 1
- Public Version Date
- 2021-04-09
- Public Version Status
- New
- Public Device Record Key
- 7d723950-776b-40cb-8892-e31e5ee44e8b
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 |
|---|---|---|---|---|
| HPT | Perimeter, Automatic, Ac-Powered | Ophthalmic | 886.1605 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59259 | Macular pigment analyser | A mains electricity (AC-powered) computerized device designed for the noninvasive in vivo measurement of macular pigment optical density (MPOD) used in the evaluation of age-related macular degeneration (AMD). It is a portable unit that includes a light-emitting diode (LED) board intended to evaluate a patient who looks down an ocular lens and responds to a flickering spot (heterochromatic flicker photometry); after a series of presentations a value for the MPOD is calculated and displayed. The device may be used in association with dedicated software installed on a personal computer; it may be used in healthcare facilities or in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017803005 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091579 | 000 |