FDA.reportPublic FDA data

Malibu

Primary DI
06974213566148
Brand
Malibu
Company
WENZHOU TIDE-OPTICAL CO.,LTD
Model
6223
Published
2026-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
16974213560556PackageGS112In Commercial Distribution
26974213560140PackageGS125In Commercial Distribution
06974213566148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697421356055616974213560556
2697421356014026974213560140
06974213566148069742135661486974213566148

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0
Length0
Weight0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool dry place, avoid high temperature and direct sunlight; keep away from chemical corrosives.

Regulatory Flags#

DUNS number
539961200
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
06974213565783Malibu62232026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16977551440818No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440825No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440955No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
16977551440962No brandSANMEN HONGYU GLASSES CO., LTDHQY2026-10-25
06977198050015DuyingTaizhou Duying GLASSES Co., Ltd.HQY2026-10-24
08800348923892Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923915Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923922Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923939Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
08800348923946Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-23
06973541158643REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
06973541158650REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
06973541158667REC TRANS BLU LT SUNGLASSESTaizhou YuanMing Glasses Co., LtdHQY2026-10-22
16973541158336SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
16973541158343SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158166SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158173SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158180SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158197SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158203SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158210SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158333SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
26973541158340SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-10-21
08800348923779Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923786Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923793Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923809Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923816Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923823Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20
08800348923830Blue ElephantBlue Elephant Co.,Ltd.HQY2026-10-20