FDA.reportPublic FDA data

ICU Eyewear

Primary DI
00078041048275
Brand
ICU Eyewear
Company
ZOOM EYEWORKS DBA ICU EYEWEAR, INC.
Model
71850104
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HOISpectacle, magnifying
HQYSunglasses (non-prescription including photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00078041048275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00078041048275000780410482750780410482750078041048275

GMDN Terms#

Term, Definition table
TermDefinition
Magnifying spectaclesA device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001952241
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00078041002383ICU Eyewear10580205ZX2022-12-01
00078041003120ICU Eyewear201501012022-12-01
00078041003137ICU Eyewear201501022022-12-01
00078041003144ICU Eyewear201501032022-12-01
00078041003151ICU Eyewear201501042022-12-01
00078041003168ICU Eyewear201501062022-12-01
00078041003175ICU Eyewear201501072022-12-01
00078041003182ICU Eyewear201501082022-12-01
00078041003199ICU Eyewear201501052022-12-01
00078041013884ICU Eyewear503092082022-12-01
00078041014010ICU Eyewear702200082022-12-01
00078041036722ICU Eyewear702200012022-12-01
00078041036739ICU Eyewear702200022022-12-01
00078041036746ICU Eyewear702200032022-12-01
00078041036753ICU Eyewear702200042022-12-01
00078041036777ICU Eyewear702200062022-12-01
00078041048251ICU Eyewear718501022022-12-01
00078041048268ICU Eyewear718501032022-12-01
00078041048299ICU Eyewear718501062022-12-01
00078041048305ICU Eyewear718501082022-12-01

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