FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800348923946
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
VISS purple brown
Published
2026-10-23
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
08800348923946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800348923946088003489239468800348923946

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
08800348923892Blue ElephantCONNIE-S black2026-10-23
08800348923915Blue ElephantMIMI black2026-10-23
08800348923922Blue ElephantRUEL-S black2026-10-23
08800348923939Blue ElephantLYRA red wine2026-10-23
08800348923779Blue ElephantDOVE-S silver2026-10-20
08800348923786Blue ElephantDOVE-S black2026-10-20
08800348923793Blue ElephantDOVE silver2026-10-20
08800348923809Blue ElephantDOVE black2026-10-20
08800348923816Blue ElephantSAINT pearl grey2026-10-20
08800348923823Blue ElephantSAINT olive2026-10-20
08800348923830Blue ElephantSAINT nude pink2026-10-20
08800348923847Blue ElephantSAINT black2026-10-20
08800348923854Blue ElephantRIMI-S brown2026-10-20
08800348923861Blue ElephantRIMI gold2026-10-20
08800348923878Blue ElephantRIMI black2026-10-20
08800348923885Blue ElephantVIAN-S leopard (N)2026-10-20
08800332269982Blue ElephantMUV black2026-10-01
08800332269999Blue ElephantMUV jelly green2026-10-01
08800348923755Blue ElephantMUV pine crystal2026-10-01
08800348923762Blue ElephantVEIL nude jade2026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16977551440818No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440825No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440955No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440962No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
06977198050015DuyingTaizhou Duying GLASSES Co., Ltd.HQY2026-10-24
08800348923892Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923915Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923922Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923939Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
06973541158643REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
06973541158650REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
06973541158667REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
16973541158336SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
16973541158343SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158166SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158173SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158180SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158197SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158203SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158210SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158333SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158340SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
08800348923779Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923786Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923793Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923809Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923816Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923823Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923830Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923847Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20