FDA.reportPublic FDA data

PuriLens Plus Disinfecting System

Primary DI
00830002000063
Brand
PuriLens Plus Disinfecting System
Company
LIFESTYLE CO INC, THE
Model
MS0610/H
Device description
Starter Kit contents: Electrical voltage adapter, PuriLens Unit, removable cleaning/disinfecting chamber, two 4-oz. (120-mL) bottles PuriLens Plus Preservative-free Saline, instruction booklet.
Published
2021-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPNAccessories, Soft Lens Products
LYLAccessories, Solution, Ultrasonic Cleaners For Lenses

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPNAccessories, Soft Lens ProductsOphthalmic2
LYLAccessories, Solution, Ultrasonic Cleaners For LensesOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00830002000063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00830002000063008300020000638300020000630830002000063

GMDN Terms#

Term, Definition table
TermDefinition
Contact lens rinsing solutionA sterile solution intended to be used to rinse debris or chemical agents from contact lenses (soft or rigid) prior to insertion; it may be intended to be used during storage or heat disinfection of contact lenses, or to dilute other contact lens solutions (e.g., contact lens protein-removal solution). It is an aqueous saline solution containing preservatives [e.g., edetate disodium (EDTA)] and buffering agents; it does not contain disinfecting, protein-removal, cleaning, or wetting agents. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8006220777lenses@lifestylecompany.com

Regulatory Flags#

DUNS number
946065000
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00830002001015SGPtelefocon A2017-09-24
00830002002012SGP IItelefocon B2017-09-24
00830002003019SGP 3unifocon A2017-09-24
00830002000018PuriLens Plus Preservative Free Saline4 oz. (120 mL) Bottle2021-09-24
00830002000094PuriLens Plus Preservative Free Saline2 oz. (60 mL) Bottle2021-09-24
00830002000032PuriLens Plus Disinfecting System Lens BasketMS0610/H2021-09-24
00830002000049PuriLens Plus Disinfecting System Cleaning ChamberMS0610/H2021-09-24
00830002000056PuriLens Plus Disinfecting System Exchange KitMS0610/H2021-09-24
00830002000070PuriLens Plus Disinfecting System 110V AdapterMS0610/H2021-09-24
00830002000087PuriLens Plus Preservative Free Saline4 oz. (120 mL) Bottle2021-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049584037794WE CARE Multi-Purpose-Solution, 100 mlOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungLPN2026-07-30
04049584037800WE CARE Multi-Purpose-Solution, 360 mlOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungLPN2026-07-30
00194346672837EquateWAL-MART STORES, INC.LPN2026-06-23
00194346672844EquateWAL-MART STORES, INC.LPN2026-06-23
00310119041024Bausch + LombBausch & Lomb IncorporatedLYL2026-01-09
00310119041062Bausch + LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041086Bausch & LombBausch & Lomb IncorporatedLPN2026-01-09
00310119041406Bausch + LombBausch & Lomb IncorporatedLYL2026-01-09
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
00713733806695MeijerMEIJER, INC.LYL2024-12-16
00713733806701MeijerMEIJER, INC.LYL2024-12-16
00713733806718MeijerMEIJER, INC.LYL2024-12-16
00713733806886MeijerMEIJER, INC.LYL2024-12-16
00194346415397EquateWAL-MART STORES, INC.LPN2024-12-05
00310119041307Target saline solution sensitive eyesTARGET CORPORATIONLPN2024-07-16
00310119304488Target moisture balance advanced multi-purpose solutionTARGET CORPORATIONLYL2024-07-16
00310119304495up & up multipurpose solutionTARGET CORPORATIONLPN2024-07-16
00606492119079HydroPureOte North America LLCLPN2024-07-15
00606492119086HydroPureOte North America LLCLPN2024-07-10
00310119304471WalgreensWALGREEN CO.LYL2024-07-01