FDA.reportPublic FDA data

PuriLens Plus Preservative Free Saline

Primary DI
00830002000087
Brand
PuriLens Plus Preservative Free Saline
Company
LIFESTYLE CO INC, THE
Model
4 oz. (120 mL) Bottle
Device description
PuriLens Plus Preservative-Free Saline is a sterile, non-preserved, aqueous, isotonic solution of sodium chloride, buffered with boric acid and sodium borate. PuriLens Plus Preservative-Free Saline is sterilized and packaged using aseptic processing (blow- fill-seal).
Published
2021-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRCProducts, Contact Lens Care, Rigid Gas Permeable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRCProducts, Contact Lens Care, Rigid Gas PermeableOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00830002000025PackageGS112In Commercial Distribution
00830002000087PackageGS13In Commercial Distribution
00830002000124PackageGS16In Commercial Distribution
00830002000018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00830002000025008300020000258300020000250830002000025
00830002000087008300020000878300020000870830002000087
00830002000124008300020001248300020001240830002000124
00830002000018008300020000188300020000180830002000018

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
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
00830002000063PuriLens Plus Disinfecting SystemMS0610/H2021-09-24
00830002000070PuriLens Plus Disinfecting System 110V AdapterMS0610/H2021-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00095072096006Up&Up TARGET CORPORATIONMRC2026-04-22
00198168143803 Tangible Fill DRY EYE INNOVATIONS, LLCMRC2026-04-22
00850013056071VibrantVueDRY EYE INNOVATIONS, LLCMRC2025-12-01
00850013056095VibrantVue DRY EYE INNOVATIONS, LLCMRC2025-12-01
00196527447258Zenlens Patient KitBausch & Lomb IncorporatedMRC2025-06-17
00713733766173MeijerMEIJER, INC.MRC2024-10-23
00713733766197MeijerMEIJER, INC.MRC2024-10-23
00198168596739Tangible Clean Sample BottleTANGIBLE SCIENCE, INC.MRC2024-04-22
00198168983577Tangible CleanTANGIBLE SCIENCE, INC.MRC2024-04-22
00860005853410Aqua Naina Sterile Saline Solution Chemtex USA Inc.MRC2024-03-20
00310119022771Biotrue® Hydration Boost Contact Lens Rehydrating DropsBausch & Lomb IncorporatedMRC2023-10-25
00310119303696ScleralFilBausch & Lomb IncorporatedMRC2023-07-05
00364108422301LensGieneOPTICS LABORATORY, INC.MRC2023-05-05
00364108422011LensGieneOPTICS LABORATORY, INC.MRC2023-05-05
00310119022498Biotrue® Hydration Boost Contact Lens Rehydrating DropsBausch & Lomb IncorporatedMRC2023-04-27
00850012123019NutrifillCONTAMAC SOLUTIONS, INC.MRC2022-08-04
00830002000018PuriLens Plus Preservative Free SalineLIFESTYLE CO INC, THEMRC2021-09-24
00830002000094PuriLens Plus Preservative Free SalineLIFESTYLE CO INC, THEMRC2021-09-24
00681131176361EquateWAL-MART STORES, INC.MRC2020-11-17
00681131179119EquateWAL-MART STORES, INC.MRC2020-11-17
00681131179126EquateWAL-MART STORES, INC.MRC2020-11-17
00850012123002NutrifillCONTAMAC SOLUTIONS, INC.MRC2020-08-20
00310119303818up & up rigid gas permeable contact lens conditioning solutionTARGET CORPORATIONMRC2020-06-05
00310119054536Bausch + LombBausch & Lomb IncorporatedMRC2020-05-28
00310119054543Bausch + LombBausch & Lomb IncorporatedMRC2020-05-28
00310119054550Bausch + LombBausch & Lomb IncorporatedMRC2020-05-28
00047113709338CLEAR CAREAlcon Laboratories, Inc.MRC2020-02-25
00858961791037up & up rigid gas permeable contact lens conditioning solutionTARGET CORPORATIONMRC2019-04-23