FDA.report

Blue Elephant

Primary DI
08800332266813
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
SINKER brown
Published
2026-01-07
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

Related Records

Product Codes

CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800332266813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800332266813088003322668138800332266813

GMDN Terms

TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips 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 by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Sterilization Methods

Method

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 DIBrandModelCatalogPublished
08800332268442Blue ElephantDRUKI leopard2026-01-29
08800332268459Blue ElephantDRUKI grey2026-01-29
08800332268466Blue ElephantDRUKI black2026-01-29
08800332268473Blue ElephantDRUKI ash brown2026-01-29
08800332268480Blue ElephantBANDI-S purple crystal2026-01-29
08800332268497Blue ElephantBANDI-S nude beige2026-01-29
08800332268503Blue ElephantBANDI-S leopard2026-01-29
08800332268510Blue ElephantBANDI-S black2026-01-29
08800332260293Blue ElephantYUKI brick2026-01-28
08800332260309Blue ElephantYUKI khaki 2026-01-28
08800332260613Blue ElephantSIGMA nude beige2026-01-28
08800332260972Blue ElephantSOL matte black2026-01-28
08800332260989Blue ElephantSOL matte silver2026-01-28
08800332261030Blue ElephantTIMMY ash brown2026-01-28
08800332261047Blue ElephantTIMMY brick2026-01-28
08800332261054Blue ElephantVIAN ash brown2026-01-28
08800332261061Blue ElephantVIAN black2026-01-28
08800332261078Blue ElephantVIAN brick2026-01-28
08800332261627Blue ElephantWILO black2026-01-28
08800332261634Blue ElephantWILO gold2026-01-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16977551440368HIT PROMOTIONAL PRODUCTS, INC.SANMEN HONGYU GLASSES CO., LTDHQY2026-03-06
16977551440375Gold Bond IncSANMEN HONGYU GLASSES CO., LTDHQY2026-03-06
00676190867831Superflex Sun CollectionWestGroupe Optical IncHQY2026-03-02
00676190867879Superflex Sun CollectionWestGroupe Optical IncHQY2026-03-02
00676190867916Superflex Sun CollectionWestGroupe Optical IncHQY2026-03-02
00676190867954Superflex Sun CollectionWestGroupe Optical IncHQY2026-03-02
00676190867992Superflex Sun CollectionWestGroupe Optical IncHQY2026-03-02
00676190875461One True Pair SunWestGroupe Optical IncHQY2026-03-02
00676190875508One True Pair SunWestGroupe Optical IncHQY2026-03-02
00676190875546One True Pair SunWestGroupe Optical IncHQY2026-03-02
00676190875584One True Pair SunWestGroupe Optical IncHQY2026-03-02
00676190875621One True Pair SunWestGroupe Optical IncHQY2026-03-02
00676190875669One True Pair SunWestGroupe Optical IncHQY2026-03-02
00754317228700Valerie SpencerNew York EyeHQY2026-02-20
08800332268442Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-29
08800332268459Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-29
08800332268466Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-29
08800332268473Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-29
08800332268480Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-29
08800332268497Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-29
08800332268503Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-29
08800332268510Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-29
08800332268190Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-28
08800332268206Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-28
08800332268213Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-28
08800332268220Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-28
08800332268237Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-28
08800332268244Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-28
08800332268251Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-28
08800332268268Blue ElephantBlue Elephant Co.,Ltd.HQY2026-01-28