AccessGUDID - DEVICE: Humphrey Field Analyzer 3 (HFA3) (04057748085246)

GUDID

Device Identifier (DI) Information

Brand Name: Humphrey Field Analyzer 3 (HFA3)
Version or Model: 830
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Carl Zeiss Meditec, Inc.

Primary DI Number: 04057748085246
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 362747011 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HPT	Perimeter, Automatic, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1cde503d-6f2d-4243-b80a-70f51088676d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 11, 2017