FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 06951214400091
·
Model: APS-6000BER
·
Chongqing Kanghuaruiming S&T Co., Ltd..
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 06951214400091
- Version / Model
- APS-6000BER
- Company Name
- Chongqing Kanghuaruiming S&T Co., Ltd..
- Labeler DUNS
- 543066376
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-22
- Public Version
- 1
- Public Version Date
- 2018-04-23
- Public Version Status
- New
- Public Device Record Key
- e1b2d5bd-0121-4991-8740-a75eb5c73890
Device Description
The projection perimeters is used to check the sensitivity of the human eye to light(visual acuity). Ambient light by refraction system to the retina, the retinal photochemical reactions by bioelectrical, transmitted through the visual pathway visual cortex, the brain through a comprehensive analysis of the formation of vision. Any part of the distribution from the retina to the visual cortex nerve fibers, direction, known as the road lesions occur, it will be reflected in the vision, visual field changes according to the results of other tests and clinical, can analyze the site of the lesion, nature and prognosis.
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 16918 | Perimeter, automatic | A mains electricity (AC-powered), automatically operated, diagnostic, ophthalmic instrument intended for assessing the extent of the patient's peripheral visual field. Small luminous points (spots) are automatically displayed in various random positions and patient response is automatically recorded. The print-out (chart) then shows the resulting curve of the visual field. Such types include Humphrey perimeters. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06951214400091 | GS1 |