HD Analyzer

Basic Information

• Brand Name: HD Analyzer
• Primary DI: 18437014903024
• Version / Model: .OQAS
• Catalog Number: .OQAS
• Company Name: VISIOMETRICS SL
• Labeler DUNS: 465168057
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-21
• Public Version: 2
• Public Version Date: 2022-12-15
• Public Version Status: Update
• Public Device Record Key: eb837d68-6764-46f3-be32-d569174089dd

Device Description

HD Analyzer Optical Quality Analysis System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
NCF	Aberrometer, ophthalmic	Ophthalmic	886.1760	1
PJZ	Camera, ophthalmic, general-use	Ophthalmic	886.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36386	Automated ophthalmic refractometer	An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.	No	Active
62592	Meibomian gland camera	A mains electricity (AC-powered) optical device intended for infrared (IR) image capture of the meibomian glands for evaluation of structural abnormalities of the meibomian glands. It includes patient head/chin supports, an IR source(s), IR camera, controls and appropriate software intended to enable analysis of the images; it may include an eyelid everter to assist imaging of the meibomian glands.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18437014903024	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius