FDA.reportPublic FDA data

ZonedIn Contact Lenses

Primary DI
00810040145070
Brand
ZonedIn Contact Lenses
Company
ZONEDIN VISION, LLC
Model
HD0425BO
Catalog number
HD0425BO
Device description
Hioxifilcon D monthly soft contact lens -4.25 power (Boxes)
Published
2020-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPLLenses, soft contact, daily wear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040145582PrimaryGS10
00810040145070Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040145582008100401455828100401455820810040145582
00810040145070008100401450708100401450700810040145070

GMDN Terms#

Term, Definition table
TermDefinition
Soft corrective contact lens, daily-disposableA soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be discarded each day after removal. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117142079
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
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
00810040146244ZonedIn Vision Contact Lenses0010012021-01-22
00810040146251ZonedIn Vision Contact Lenses0020022021-01-22
00810040146268ZonedIn Vision Contact Lenses0030032021-01-22
00810040146275ZonedIn Vision Contact Lenses0040042021-01-22
00810040146282ZonedIn Vision Contact Lenses0050052021-01-22
00810040146299ZonedIn Vision Contact Lenses0060062021-01-22
00810040146305ZonedIn Vision Contact Lenses0070072021-01-22
00810040146312ZonedIn Vision Contact Lenses0080082021-01-22
00810040146329ZonedIn Vision Contact Lenses0090092021-01-22
00810040146336ZonedIn Vision Contact Lenses0100102021-01-22
00810040146343ZonedIn Vision Contact Lenses0110112021-01-22
00810040146350ZonedIn Vision Contact Lenses0120122021-01-22
00810040146367ZonedIn Vision Contact Lenses0130132021-01-22
00810040146374ZonedIn Vision Contact Lenses0140142021-01-22
00810040146381ZonedIn Vision Contact Lenses0150152021-01-22
00810040146398ZonedIn Vision Contact Lenses0160162021-01-22
00810040146404ZonedIn Vision Contact Lenses0170172021-01-22
00810040146411ZonedIn Vision Contact Lenses0180182021-01-22
00810040146428ZonedIn Vision Contact Lenses0190192021-01-22
00810040146435ZonedIn Vision Contact Lenses0200202021-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00847835000184FlexlensX-Cel Specialty ContactsLPL2026-02-25
08800071419518Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-18
08800071415435Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419310Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419327Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419334Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419341Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419358Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419365Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419372Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419389Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419396Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419402Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419419Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419426Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419433Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419440Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419457Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419464Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419471Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419488Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419495Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419501Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419525Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419532Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419549Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419563Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419570Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419587Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
08800071419594Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11