ZonedIn Contact Lenses

Primary DI
00810040145421
Brand
ZonedIn Contact Lenses
Company
ZONEDIN VISION, LLC
Model
HD1375BO
Catalog number
HD1375BO
Device description
Hioxifilcon D monthly soft contact lens +3.75 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
MVNLens, contact, (disposable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVNLens, Contact, (Disposable)Ophthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040145353PrimaryGS10
00810040145421Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040145353008100401453538100401453530810040145353
00810040145421008100401454218100401454210810040145421

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
00810040144066ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144257ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144264ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144271ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144288ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144295ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144301ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144318ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144325ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144332ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144349ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144356ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144363ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144370ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144387ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144394ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144400ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144417ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144424ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144431ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144448ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144455ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144462ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144479ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144486ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144493ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144509ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144516ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144523ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05
00810040144530ZonedIn Contact LensesZONEDIN VISION, LLCMVN2020-03-05