NA

Basic Information

• Brand Name: NA
• Primary DI: 06951214400237
• Version / Model: APS-6000AER
• 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: db18bd88-cdf4-4390-83a6-ec15db4ec973

Device Description

The projection perimeter 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	06951214400237	GS1