AccessGUDID - DEVICE: NA (06951214400237)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: APS-6000AER
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Chongqing Kanghuaruiming S&T Co., Ltd..

Primary DI Number: 06951214400237
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 543066376 *Terms of Use

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

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):	Yes
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: db18bd88-cdf4-4390-83a6-ec15db4ec973
Public Version Date: April 23, 2018
Public Version Number: 1
DI Record Publish Date: March 22, 2018