FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800332260910
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
KALI crystal
Published
2026-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08800332260910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800332260910088003322609108800332260910

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695736511
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800348920907Blue ElephantBLAIR black2026-07-22
08800348920914Blue ElephantBLAIR green2026-07-22
08800348920921Blue ElephantBLAIR leopard2026-07-22
08800348920938Blue ElephantBLAIR plum2026-07-22
08800348920945Blue ElephantFONI black2026-07-22
08800348920952Blue ElephantFONI leopard2026-07-22
08800348920969Blue ElephantFONI pearl pink2026-07-22
08800348920976Blue ElephantREY black2026-07-22
08800348920983Blue ElephantREY leopard2026-07-22
08800348920990Blue ElephantREY navy2026-07-22
08800348921003Blue ElephantREY plum2026-07-22
08800348921010Blue ElephantSID black2026-07-22
08800348921027Blue ElephantSID green2026-07-22
08800348921034Blue ElephantSID leopard2026-07-22
08800348921041Blue ElephantSOUR black2026-07-22
08800348921058Blue ElephantSOUR pine crystal2026-07-22
08800348921065Blue ElephantSOUR-S black2026-07-22
08800348921072Blue ElephantSOUR-S jelly green2026-07-22
08800348921089Blue ElephantSOUR-S leopard2026-07-22
08800348921096Blue ElephantZEST black2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800348921041Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921058Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921096Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921102Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
03701629015006Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-07-21
08800348920501Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920518Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920587Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920594Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920600Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920617Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920662Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920679Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920716Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920723Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920730Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920778Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920785Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920860Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
04066209006799FielmannFielmann Group AGHQZ2026-07-14
04066209008311FielmannFielmann Group AGHQZ2026-07-14
04066209008885FielmannFielmann Group AGHQZ2026-07-14
04066209045118FielmannFielmann Group AGHQZ2026-07-14
04066209054578FielmannFielmann Group AGHQZ2026-07-14
04580822703694EYEVANEYEVAN INC.HQZ2026-07-10
04580822703724EYEVANEYEVAN INC.HQZ2026-07-10
04580822703731EYEVANEYEVAN INC.HQZ2026-07-10
04580822703748EYEVANEYEVAN INC.HQZ2026-07-10
04580822704264EYEVANEYEVAN INC.HQZ2026-07-10
04580822704271EYEVANEYEVAN INC.HQZ2026-07-10