FDA.reportPublic FDA data

Blue Elephant

Primary DI
08800332269944
Brand
Blue Elephant
Company
Blue Elephant Co.,Ltd.
Model
MIMI red wine
Published
2026-05-22
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
08800332269944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800332269944088003322699448800332269944

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
08800332269951Blue ElephantZAYO-S gold2026-06-02
08800332269531Blue ElephantBALOA black2026-05-22
08800332269548Blue ElephantBALOA brick2026-05-22
08800332269586Blue ElephantDUBON-S leopard2026-05-22
08800332269593Blue ElephantHAYDEN-S black2026-05-22
08800332269616Blue ElephantJENNER black2026-05-22
08800332269623Blue ElephantJENNER red wine2026-05-22
08800332269630Blue ElephantKALO-S black2026-05-22
08800332269647Blue ElephantKALO-S brown crystal2026-05-22
08800332269654Blue ElephantLEILA-S black2026-05-22
08800332269661Blue ElephantMARINA-S black2026-05-22
08800332269678Blue ElephantMIKA-S black2026-05-22
08800332269685Blue ElephantMIMI-S blue green2026-05-22
08800332269692Blue ElephantMINCO black2026-05-22
08800332269708Blue ElephantMINCO brick2026-05-22
08800332269715Blue ElephantMINCO brown2026-05-22
08800332269722Blue ElephantMOSA black2026-05-22
08800332269739Blue ElephantMUSE black2026-05-22
08800332269746Blue ElephantNADIA black2026-05-22
08800332269753Blue ElephantNEMO-S black2026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435304380985ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304381944ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304375615ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375622ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375639ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304379262ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388721ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388745ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304355259ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355266ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355273ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355310ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355327ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304361915ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361953ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361052ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361090ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361113ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361137ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361175ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-16
08435304361977ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304361991ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304388806ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304389858ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304391165ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304379279ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304383085ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304388585ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304369003ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30
08435304379200ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30