FDA UDI
In Commercial Distribution
🇺🇸 United States
KOWA AP-7000
DI: 04987646805113
·
Model: FT10K
·
KOWA COMPANY,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KOWA AP-7000
- Primary DI
- 04987646805113
- Version / Model
- FT10K
- Company Name
- KOWA COMPANY,LTD.
- Labeler DUNS
- 692281073
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-08
- Public Version
- 1
- Public Version Date
- 2019-02-08
- Public Version Status
- New
- Public Device Record Key
- d00a06db-8137-490a-aaf8-c83984197800
Device Description
KOWA AP-7000 is an automatic perimeter to perform perimetry examinations and to display and output examination results. Static quantitative perimetry examinations and kinetic perimetry examinations are available.
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
- No
- 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 |
|---|---|---|---|---|
| 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 | 04987646805113 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 700 | Millimeter | |
| Depth | 430 | Millimeter | |
| Width | 730 | Millimeter | |
| Weight | 26 | Kilogram |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -15 – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius