FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800348920402
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
ROTO-S black
Published
2026-06-25
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
08800348920402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800348920402088003489204028800348920402

GMDN Terms#

Term, Definition table
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.

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
08800348920242Blue ElephantKELLY black2026-06-25
08800348920259Blue ElephantKELLY crystal2026-06-25
08800348920266Blue ElephantROTO black2026-06-25
08800348920273Blue ElephantROTO leopard2026-06-25
08800348920280Blue ElephantCAMI black2026-06-25
08800348920297Blue ElephantCAMI deep brown2026-06-25
08800348920303Blue ElephantCAMI grey crystal2026-06-25
08800348920310Blue ElephantCAMI leopard2026-06-25
08800348920327Blue ElephantKELLY-S black2026-06-25
08800348920334Blue ElephantKELLY-S brick crystal2026-06-25
08800348920341Blue ElephantKELLY-S grey2026-06-25
08800348920358Blue ElephantKELLY-S leopard2026-06-25
08800348920365Blue ElephantMODIQ black2026-06-25
08800348920372Blue ElephantMODIQ grey2026-06-25
08800348920389Blue ElephantMODIQ khaki2026-06-25
08800348920396Blue ElephantMODIQ leopard2026-06-25
08800348920419Blue ElephantROTO-S brown2026-06-25
08800348920426Blue ElephantVIERA black2026-06-25
08800348920433Blue ElephantVIERA brown2026-06-25
08800348920440Blue ElephantVIERA jelly green2026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209038196FielmannFielmann Group AGHQY2026-07-06
04066209038202FielmannFielmann Group AGHQY2026-07-06
04066209038219FielmannFielmann Group AGHQY2026-07-06
04066209053885FielmannFielmann Group AGHQY2026-07-06
04066209060180FielmannFielmann Group AGHQY2026-07-06
04066209060197FielmannFielmann Group AGHQY2026-07-06
04066209060203FielmannFielmann Group AGHQY2026-07-06
04066209060265FielmannFielmann Group AGHQY2026-07-06
04066209060289FielmannFielmann Group AGHQY2026-07-06
04066209060388FielmannFielmann Group AGHQY2026-07-06
04066209060470FielmannFielmann Group AGHQY2026-07-06
04066209060845FielmannFielmann Group AGHQY2026-07-06
04066209061132FielmannFielmann Group AGHQY2026-07-06
04066209063570FielmannFielmann Group AGHQY2026-07-06
04066209064416FielmannFielmann Group AGHQY2026-07-06
04066209064430FielmannFielmann Group AGHQY2026-07-06
04066209064874FielmannFielmann Group AGHQY2026-07-06
06973541158131SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-07-06
16973541158138SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-07-06
06974213566148MalibuWENZHOU TIDE-OPTICAL CO.,LTDHQY2026-07-03
08800348920280Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920297Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920303Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920310Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920327Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920334Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920341Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920358Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920365Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920372Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25