FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800348923502
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
TAKI-S khaki
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
08800348923502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800348923502088003489235028800348923502

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
08800348923403Blue ElephantDUNGA-S black2026-08-14
08800348923410Blue ElephantDUNGA-S black crystal2026-08-14
08800348923427Blue ElephantDUNGA-S leopard2026-08-14
08800348923434Blue ElephantMARINA leopard2026-08-14
08800348923441Blue ElephantMARINA-S leopard2026-08-14
08800348923458Blue ElephantMINCO grey crystal2026-08-14
08800348923465Blue ElephantNANIA purple crystal2026-08-14
08800348923472Blue ElephantTAKI black2026-08-14
08800348923489Blue ElephantTAKI leopard2026-08-14
08800348923496Blue ElephantTAKI-S grey crystal2026-08-14
08800348923519Blue ElephantTAKI-S leopard2026-08-14
08800332261580Blue ElephantVIGOR black2026-07-31
08800332261597Blue ElephantVIGOR deep brown2026-07-31
08800332261603Blue ElephantVIGOR leopard2026-07-31
08800332261610Blue ElephantVIGOR nude beige2026-07-31
08800332263010Blue ElephantRINOX grey crystal2026-07-31
08800332263041Blue ElephantRINOX purple2026-07-31
08800332263584Blue ElephantVILLA ash brown2026-07-31
08800332263614Blue ElephantVILLA leopard2026-07-31
08800332264765Blue ElephantFOSSE black2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00754317216479Ernest HemingwayNew York EyeHQY2026-08-17
00754317216486Ernest HemingwayNew York EyeHQY2026-08-17
00754317218022Ernest HemingwayNew York EyeHQY2026-08-17
00754317218039Ernest HemingwayNew York EyeHQY2026-08-17
00754317228151Valerie SpencerNew York EyeHQY2026-08-17
00754317228618Marc HunterNew York EyeHQY2026-08-17
00754317228625Marc HunterNew York EyeHQY2026-08-17
00754317228632Marc HunterNew York EyeHQY2026-08-17
00754317228649Marc HunterNew York EyeHQY2026-08-17
00754317228656Valerie SpencerNew York EyeHQY2026-08-17
00754317228663Valerie SpencerNew York EyeHQY2026-08-17
00754317228670Valerie SpencerNew York EyeHQY2026-08-17
00754317228687Valerie SpencerNew York EyeHQY2026-08-17
00754317228694Valerie SpencerNew York EyeHQY2026-08-17
00754317228731Ernest HemingwayNew York EyeHQY2026-08-17
00754317228748Ernest HemingwayNew York EyeHQY2026-08-17
08800348923403Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923410Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923427Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923441Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923458Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923465Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923496Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923519Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
06980076270009GaoqiuTaizhou Gaoqiu Glasses Co., Ltd.HQY2026-08-07
08800332263010Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332263041Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332263584Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332263614Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332264765Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31