FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800348924004
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
VEXI gold
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
HQZFrame, Spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800348924004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800348924004088003489240048800348924004

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle frameAn ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).

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
08800348924011Blue ElephantVEXI silver2026-10-29
08800348924028Blue ElephantVEXI-S gunmetal2026-10-29
08800348924035Blue ElephantVEXI-S silver2026-10-29
08800348924042Blue ElephantDOBA-S brown2026-10-29
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
08800348923991Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924011Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924066Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924073Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924080Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924127Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924134Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924219Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924226Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924264Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924271Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924295Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924301Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924318Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924325Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924370Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924387Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924394Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924400Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08800348924417Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-10-29
08447504040095ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040132ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040170ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040217ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040255ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040293ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040330ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040378ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040736ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040774ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26