FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800348923472
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
TAKI black
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
HQZFrame, Spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800348923472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800348923472088003489234728800348923472

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle frameAn ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).

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
08800348923946Blue ElephantVISS purple brown2026-10-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08447504030140ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030188ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030225ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030263ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030560ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030607ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030645ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030683ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030720ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030768ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030805ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030843ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030881ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504033899ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504033936ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504033974ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034018ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034056ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034094ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034131ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034179ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034216ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034254ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034292ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034339ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034377ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034414ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034452ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034490ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034537ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22