FDA UDI
In Commercial Distribution
🇺🇸 United States
Humphrey Field Analyzer 3 (HFA3)
DI: 04057748085253
·
Model: 840
·
Carl Zeiss Meditec, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Humphrey Field Analyzer 3 (HFA3)
- Primary DI
- 04057748085253
- Version / Model
- 840
- Company Name
- Carl Zeiss Meditec, Inc.
- Labeler DUNS
- 362747011
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-11
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- fe09d954-4269-44c2-8446-c4157a423f8c
Device Description
The Humphrey Field Analyzer is an automated perimeter intended to identify visual field defects for the purposes of screening, monitoring and assisting in the diagnosis of ocular and neurological disorders including glaucoma.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 | 04057748085253 | GS1 |