FDA.reportPublic FDA data

2004-E

Primary DI
16973881680078
Brand
2004-E
Company
Tianjin Newtrans Technology Development
Model
2004-E
Published
2023-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
26973881680075PackageGS1300In Commercial Distribution
16973881680078PrimaryGS10
06973881680057Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697388168007526973881680075
1697388168007816973881680078
06973881680057069738816800576973881680057

GMDN Terms#

Term, Definition table
TermDefinition
Prescription spectaclesAn ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) designed to be worn in front of the user's eyes to provide refractive corrections to eyesight conditions such as presbyopia (the eye's diminished power of accommodation that occurs with ageing), or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted (sunglasses) to protect the eyes from bright light and radiation.

Regulatory Flags#

DUNS number
527173399
Device count
50
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16973881680153N/A1010-C2023-03-03
16973881680160N/A1007-E2023-03-03
16973881680177N/A1001-C2023-03-03
16973881680191N/A1003-C2023-03-03
16973881680207N/A1011-C2023-03-03
26973881680143N/A1010-C2023-03-03
26973881680150N/A1007-E2023-03-03
26973881680167N/A1001-C2023-03-03
26973881680181N/A1003-C2023-03-03
26973881680198N/A1011-C2023-03-03
169738816800091009-C1009-C2023-01-12
169738816800852002-E2002-E2023-01-12
169738816800922003-E2003-E2023-01-12
169738816801082005-E2005-E2023-01-12
169738816801151004-C1004-C2023-01-12
169738816801221005-C1005-C2023-01-12
169738816801391006-C1006-C2023-01-12
169738816801461008-C1008-C2023-01-12
06973881680026XinjingProWellness™1010-C2021-12-24
06973881680033XinjingProWellness™1009-C2021-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800348920907Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920914Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920921Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920938Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920945Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920952Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920969Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920976Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920983Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920990Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921003Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921010Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921027Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921034Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921065Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921072Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921089Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921119Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921126Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348921133Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920464Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920471Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920488Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920495Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920525Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920532Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920549Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920556Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920563Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20
08800348920570Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-20