FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800348923441
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
MARINA-S leopard
Published
2026-08-14
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
08800348923441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800348923441088003489234418800348923441

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
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
08800348923403Blue ElephantDUNGA-S black2026-08-14
08800348923410Blue ElephantDUNGA-S black crystal2026-08-14
08800348923427Blue ElephantDUNGA-S leopard2026-08-14
08800348923434Blue ElephantMARINA leopard2026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08800348923854Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923861Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923878Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923885Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
06973541158384SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-13
16973541158381SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-13
26973541158388SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-13
08872000401864SunglassesLEADER LAO CO., LTDHQY2026-10-09
08800332269982Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-01
08800332269999Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-01
08800348923755Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-01
08800348923762Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-01
06973541158353SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158360SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158377SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158391SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158407SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158414SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158421SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158438SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158445SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158452SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24