FDA.reportPublic FDA data

LEADER

Primary DI
50096295137144
Brand
LEADER
Company
CARDINAL HEALTH, INC.
Model
5513221
Catalog number
5513221
Device description
LDR Multipurpose Contact Lens Solution 12oz
Published
2019-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYLAccessories, solution, ultrasonic cleaners for lenses

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYLAccessories, Solution, Ultrasonic Cleaners For LensesOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50096295137144PackageGS124In Commercial Distribution
00096295137149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5009629513714450096295137144
00096295137149000962951371490962951371490096295137149

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose soft contact lens solutionA sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting reusable soft contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature025 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)200-6313xxx@xxx.xxx

Regulatory Flags#

DUNS number
097537435
Device count
1
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
true
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
10884521015920Dover20512C20512C2016-09-24
10884521015982Dover20520C20520C2016-09-24
10884521016002Dover20522C20522C2016-10-13
10884521024991Kendall924092402018-06-27
10884521025004Kendall924292422018-06-27
10884521025011Kendall924392432018-06-27
10884521025028Kendall924492442018-06-27
20192253002062Curity21462146-2018-12-12
20884521143064Magellan888183351588818335152016-09-24
10884527007110Argyle888816305588881630552016-09-24
10885380173691Curity6309G6309G2019-11-14
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10884521141148Filac5040835040832016-09-24
10884521165045Kangaroo3881063881062016-09-24
10884521000674Dover35313531-2016-09-24
10884521001046Dover625562552016-09-24
10884521001138Dover825682562016-09-24
10884521001145Dover7016727016722016-09-24
10884521001206Dover7004ICLL7004ICLL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00310119041024Bausch + LombBausch & Lomb IncorporatedLYL2026-01-09
00310119041406Bausch + LombBausch & Lomb IncorporatedLYL2026-01-09
00713733806695MeijerMEIJER, INC.LYL2024-12-16
00713733806701MeijerMEIJER, INC.LYL2024-12-16
00713733806718MeijerMEIJER, INC.LYL2024-12-16
00713733806886MeijerMEIJER, INC.LYL2024-12-16
00310119304488Target moisture balance advanced multi-purpose solutionTARGET CORPORATIONLYL2024-07-16
00310119304471WalgreensWALGREEN CO.LYL2024-07-01
00078742321738Member's MarkWAL-MART STORES, INC.LYL2024-04-15
00310119041222Member's MarkWAL-MART STORES, INC.LYL2024-04-15
00846036009606Good SenseGEISS, DESTIN & DUNN, INCLYL2024-02-13
00195515043182Amazon Basic Care AMAZON.COM SERVICES LLCLYL2023-12-12
00195515043199Amazon Basic CareAMAZON.COM SERVICES LLCLYL2023-12-12
00195515043175Amazon Basic CareAMAZON.COM SERVICES LLCLYL2023-12-12
10195515043189Amazon Basic Care AMAZON.COM SERVICES LLCLYL2023-12-12
10195515043196Amazon Basic CareAMAZON.COM SERVICES LLCLYL2023-12-12
00195515043205Amazon Basic CareAMAZON.COM SERVICES LLCLYL2023-12-12
00095072049552DG Health DOLGENCORP, LLCLYL2023-09-18
00095072100048DG Health DOLGENCORP, LLCLYL2023-09-18
00087701431982Good NeighborAmerisourcebergen Drug CorporationLYL2023-09-12
00087701190100Good NeighborAmerisourcebergen Drug CorporationLYL2023-09-11
00050428395127CVS HEALTH WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLYL2023-09-08
00311917011936WalgreensWALGREEN CO.LYL2022-05-24
00311917011943WalgreensWALGREEN CO.LYL2022-05-24
00311917012018WalgreensWALGREEN CO.LYL2022-05-24
10311917011933WalgreensWALGREEN CO.LYL2022-05-24
20311917011947WalgreensWALGREEN CO.LYL2022-05-24
20311917012012WalgreensWALGREEN CO.LYL2022-05-24
00830002000032PuriLens Plus Disinfecting System Lens BasketLIFESTYLE CO INC, THELYL2021-09-24
00830002000049PuriLens Plus Disinfecting System Cleaning ChamberLIFESTYLE CO INC, THELYL2021-09-24