FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800348920259
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
KELLY crystal
Published
2026-06-25
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
08800348920259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800348920259088003489202598800348920259

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
08800348920242Blue ElephantKELLY black2026-06-25
08800348920266Blue ElephantROTO black2026-06-25
08800348920273Blue ElephantROTO leopard2026-06-25
08800348920280Blue ElephantCAMI black2026-06-25
08800348920297Blue ElephantCAMI deep brown2026-06-25
08800348920303Blue ElephantCAMI grey crystal2026-06-25
08800348920310Blue ElephantCAMI leopard2026-06-25
08800348920327Blue ElephantKELLY-S black2026-06-25
08800348920334Blue ElephantKELLY-S brick crystal2026-06-25
08800348920341Blue ElephantKELLY-S grey2026-06-25
08800348920358Blue ElephantKELLY-S leopard2026-06-25
08800348920365Blue ElephantMODIQ black2026-06-25
08800348920372Blue ElephantMODIQ grey2026-06-25
08800348920389Blue ElephantMODIQ khaki2026-06-25
08800348920396Blue ElephantMODIQ leopard2026-06-25
08800348920402Blue ElephantROTO-S black2026-06-25
08800348920419Blue ElephantROTO-S brown2026-06-25
08800348920426Blue ElephantVIERA black2026-06-25
08800348920433Blue ElephantVIERA brown2026-06-25
08800348920440Blue ElephantVIERA jelly green2026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209026032FielmannFielmann Group AGHQZ2026-07-08
04066209033016FielmannFielmann Group AGHQZ2026-07-08
04066209033184FielmannFielmann Group AGHQZ2026-07-08
04066209040083FielmannFielmann Group AGHQZ2026-07-08
04066209044883FielmannFielmann Group AGHQZ2026-07-08
04066209046917FielmannFielmann Group AGHQZ2026-07-08
04066209046924FielmannFielmann Group AGHQZ2026-07-08
04066209047051FielmannFielmann Group AGHQZ2026-07-08
04066209049178FielmannFielmann Group AGHQZ2026-07-08
04066209051140FielmannFielmann Group AGHQZ2026-07-08
04066209051201FielmannFielmann Group AGHQZ2026-07-08
04066209052475FielmannFielmann Group AGHQZ2026-07-08
04066209052673FielmannFielmann Group AGHQZ2026-07-08
04066209052697FielmannFielmann Group AGHQZ2026-07-08
04066209052932FielmannFielmann Group AGHQZ2026-07-08
04066209055445FielmannFielmann Group AGHQZ2026-07-08
04066209055803FielmannFielmann Group AGHQZ2026-07-08
04066209056213FielmannFielmann Group AGHQZ2026-07-08
04066209058637FielmannFielmann Group AGHQZ2026-07-08
04066209058644FielmannFielmann Group AGHQZ2026-07-08
04066209058934FielmannFielmann Group AGHQZ2026-07-08
04066209059795FielmannFielmann Group AGHQZ2026-07-08
04066209060074FielmannFielmann Group AGHQZ2026-07-08
04066209060081FielmannFielmann Group AGHQZ2026-07-08
04066209060425FielmannFielmann Group AGHQZ2026-07-08
04066209060487FielmannFielmann Group AGHQZ2026-07-08
04066209060517FielmannFielmann Group AGHQZ2026-07-08
04066209063525FielmannFielmann Group AGHQZ2026-07-08
04066209063600FielmannFielmann Group AGHQZ2026-07-08
03701629014160Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-07-07