FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800348924042
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
DOBA-S brown
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800348924042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800348924042088003489240428800348924042

GMDN Terms#

Term, Definition table
TermDefinition
Non-prescription sunglassesAn optical device in the form of spectacles with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation [commonly including ultraviolet (UV)] by absorption, reflection, or polarization to protect the eyes from bright light (sunlight); it is neither intended to provide refractive corrections nor enhance colour discrimination.

Regulatory Flags#

DUNS number
695736511
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
08800348923953Blue ElephantSHAI ash brown2026-10-29
08800348923960Blue ElephantSHAI black2026-10-29
08800348923977Blue ElephantSHAI jelly green2026-10-29
08800348923984Blue ElephantSHAI leopard2026-10-29
08800348923991Blue ElephantVEXI black2026-10-29
08800348924004Blue ElephantVEXI gold2026-10-29
08800348924011Blue ElephantVEXI silver2026-10-29
08800348924028Blue ElephantVEXI-S gunmetal2026-10-29
08800348924035Blue ElephantVEXI-S silver2026-10-29
08800348924059Blue ElephantDOBA-S black2026-10-29
08800348924066Blue ElephantDOBA silver2026-10-29
08800348924073Blue ElephantDOBA gold2026-10-29
08800348924080Blue ElephantDOBA black2026-10-29
08800348924097Blue ElephantDAMON-S leopard2026-10-29
08800348924103Blue ElephantDAMON-S jelly green2026-10-29
08800348924110Blue ElephantDAMON-S black2026-10-29
08800348924127Blue ElephantDAMON leopard2026-10-29
08800348924134Blue ElephantDAMON black2026-10-29
08800348924141Blue ElephantCHET plum2026-10-29
08800348924158Blue ElephantCHET leopard2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973541158674SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-29
08800348923953Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348923960Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348923977Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348923984Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924028Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924035Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924059Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924097Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924103Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924110Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924141Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924158Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924165Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924172Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924189Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924196Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924202Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924233Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924240Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924257Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924288Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924332Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924349Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924356Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924363Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924424Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924431Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
08800348924448Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-29
16977551440818No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25