FDA.reportPublic FDA data

Cleaning & Disinfecting Lens Care System

Primary DI
00011822545358
Brand
Cleaning & Disinfecting Lens Care System
Company
RITE AID CORPORATION
Model
052
Published
2019-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true

Product Codes#

Code, Name table
CodeName
LPNAccessories, Soft Lens Products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPNAccessories, Soft Lens ProductsOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010559000SAUFLON MULTI LENS CARE SYSTEMSauflon Pharmaceuticals, Ltd.2001-12-20LPN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00011822545358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00011822545358000118225453580118225453580011822545358

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose soft/rigid contact lens solutionA sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting soft contact lenses and rigid gas permeable (RGP)/hard 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014578892
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00011822037785Rite Aid Pharmacy0118220377852020-02-24
00011822089210Rite Aid 0118220892102021-01-19
00011822089227Rite Aid 0118220892272021-01-19
00011822137010Rite Aid Pharmacy0118221370102020-01-30
00011822372091Rite Aid Pharmacy0118223720912020-04-29
00011822411219Rite Aid Pharmacy0118224112192020-01-30
00011822411554Rite Aid Pharmacy01182241155480190102021-05-24
00011822430500Rite Aid Pharmacy0118224305002020-02-10
00011822455404Rite Aid Pharmacy01182245540480189862021-05-24
00011822565561Rite Aid Pharmacy035655603565562016-09-24
00011822643146Rite Aid Pharmacy0118226431462021-06-21
00011822673686Rite Aid Pharmacy0118226736862020-01-30
00011822685948Rite Aid Pharmacy0118226859482020-01-30
00011822729475Rite Aid Pharmacy0118227294752020-01-30
00011822782128Rite Aid Pharmacy0118227821282020-04-29
00011822782135Rite Aid Pharmacy0118227821352020-04-29
00011822855617Rite Aid Pharmacy0118228556172020-08-10
00011822894807Rite Aid 0118228948072021-01-19
00011822037815Rite Aid Pharmacy01182203781503719362021-05-11
00011822001656Rite Aid80245132025-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00310119041062Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041086Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041420Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041468Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119044230Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119044247Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119304242up & up multipurpose solutionTARGET CORPORATIONLPN2026-01-09
00780707000007HydravueUnited Exchange Corp.LPN2025-05-23
00310119030189renu sensitive multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119030486renu sensitive multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119031186renu fresh multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119031223renu fresh multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00310119032220renu fresh multi-purpose solutionBausch & Lomb IncorporatedLPN2025-02-19
00194346415397EquateWAL-MART STORES, INC.LPN2024-12-05
00310119041307Target saline solution sensitive eyesTARGET CORPORATIONLPN2024-07-16
00310119304495up & up multipurpose solutionTARGET CORPORATIONLPN2024-07-16
00606492119079HydroPureOte North America LLCLPN2024-07-15
00606492119086HydroPureOte North America LLCLPN2024-07-10
00310119304501WalgreensWALGREEN CO.LPN2024-06-21
05060503857803Chromaview Multi-Purpose SolutionARCADANT B.V.LPN2024-05-22
00351801021016Vista Clean Multi-Purpose SolutionNomax, Inc.LPN2024-05-06
00351801021030Vista Clean Multi-Purpose SolutionNomax, Inc.LPN2024-05-06
00197644026180Clear ConscienceClear ConscienceLPN2024-03-21
00197644945504Clear Conscience Clear ConscienceLPN2024-03-21
00310119022771Biotrue® Hydration Boost Contact Lens Rehydrating DropsBausch & Lomb IncorporatedLPN2023-10-25
00827444001512REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09
00827444001529REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09
00827444001536REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09
00827444001550REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09
30827444001513REVITALENSJOHNSON & JOHNSON SURGICAL VISION, INC.LPN2023-10-09