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
HPT Perimeter, Automatic, Ac-Powered

GMDN Terms

Code Name
16918 Perimeter, automatic

Identifiers

Type ID
Primary 04057748085253