Home GUDID 00810750031564 EnChroma®
Primary DI 00810750031564
Brand EnChroma®
Company Enchroma Inc.
Model Derby Clear Cx2 Outdoor Shade Lens
Device description EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device only and are not a cure for color blindness. EnChroma lenses are designed for use with deuteranomalous or protanomalous color vision deficiency. The lens is not expected to assist with deuteranopia and protanopia. Effectiveness of the lens may vary depending on the type and extent of color vision deficiency. EnChroma lenses are not designed to defeat color blindness screening tests. EnChroma eyewear are not suitable for driving and road use. Tinted lenses may impair visibility in low light conditions and should not be used for driving in twilight, night, or through tunnels. When first trying on the lens, the unusual appearance of colors may be visually distracting. Always maintain awareness of potential hazards in your surroundings and take appropriate cautions when engaging in activities such as driving or operation of machinery. The lens is not certified for use in occupations where color blind individuals may be restricted for reasons of public safety, such as emergency first responders, and public transport operators. Store in a cool, dry area away from extreme temperatures as it can damage the lenses. DO NOT store the glasses inside hot vehicles.
Published 2022-12-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name HQY Sunglasses (Non-Prescription Including Photosensitive)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HQY Sunglasses (Non-Prescription Including Photosensitive) Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810750031564 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810750031564 00810750031564 810750031564 0810750031564
GMDN Terms# Term, Definition table Term Definition Colour discrimination non-prescription spectacles An ophthalmic device consisting of a spectacle frame with a pair of coloured/tinted lenses (non-refractive) designed to be worn in front of the patient’s eyes to enhance colour discrimination in patients with colour vision deficiency; it is not intended to correct refractive vision conditions and is not customized for a specific patient.
Regulatory Flags# DUNS number 963464198 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810750030031 EnChroma® Ellis Grey Cx3 Outdoor Sun Lens 2022-12-01 00810750030048 EnChroma® Ellis Brown Cx3 Outdoor Sun Lens 2022-12-01 00810750030062 EnChroma® Ellis Brown Cx1 Indoor Lens 2018 2022-12-01 00810750030079 EnChroma® Russell Black Cx2 Outdoor Shade Lens 2022-12-01 00810750030116 EnChroma® Solano Tortoise Cx3 Outdoor Sun Lens 2022-12-01 00810750030123 EnChroma® Gilman Black Cx3 Outdoor Sun Lens 2022-12-01 00810750030130 EnChroma® Twain Black Cx1 Indoor Lens 2018 2022-12-01 00810750030147 EnChroma® Twain Night Sky Cx1 Indoor Lens 2018 2022-12-01 00810750030154 EnChroma® Twain Black Cx3 Outdoor Sun Lens 2022-12-01 00810750030161 EnChroma® Twain Night Sky Cx3 Outdoor Sun Lens 2022-12-01 00810750030185 EnChroma® Panoramic XL Matte Black Cx3 Outdoor Sun Lens 2022-12-01 00810750030192 EnChroma® Ellis Brown Cx1 Indoor Lens 2022-12-01 00810750030208 EnChroma® Panoramic XL Matte Black Cx1 Indoor Lens 2022-12-01 00810750030215 EnChroma® Cx Series Professional Demo Kit - 3pc v.2022 2022-12-01 00810750030222 EnChroma® Canyon Gunmetal Cx3 Outdoor Sun SP Lens 2022-12-01 00810750030239 EnChroma® Colby Black Cx3 Outdoor Sun SP Lens 2022-12-01 00810750030246 EnChroma® Derby Black Cx3 Outdoor Sun SP Lens 2022-12-01 00810750030253 EnChroma® Derby Black Cx1 Indoor Lens 2022-12-01 00810750030277 EnChroma® Derby Tortoise Cx3 Outdoor Sun SP Lens 2022-12-01 00810750030284 EnChroma® Ellis Black Cx3 Outdoor Sun SP Lens 2022-12-01
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