PuriLens Plus Disinfecting System Exchange Kit

GUDID 00830002000056

Exchange Kit contents: PuriLens Unit and removable cleaning/disinfecting chamber.

LIFESTYLE CO INC, THE

Contact lens agitation cleaning system, mechanical
Primary Device ID00830002000056
NIH Device Record Keyb2fd4811-f6bc-4398-b54c-93f3fa833f57
Commercial Distribution StatusIn Commercial Distribution
Brand NamePuriLens Plus Disinfecting System Exchange Kit
Version Model NumberMS0610/H
Company DUNS946065000
Company NameLIFESTYLE CO INC, THE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com
Phone8006220777
Emaillenses@lifestylecompany.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100830002000056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYLAccessories, Solution, Ultrasonic Cleaners For Lenses

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-04
Device Publish Date2021-09-24

Devices Manufactured by LIFESTYLE CO INC, THE

00830002000087 - PuriLens Plus Preservative Free Saline2021-10-04 PuriLens Plus Preservative-Free Saline is a sterile, non-preserved, aqueous, isotonic solution of sodium chloride, buffered with
00830002000032 - PuriLens Plus Disinfecting System Lens Basket2021-10-04 Replacement lens basket packaged in plastic zip-lock bag.
00830002000049 - PuriLens Plus Disinfecting System Cleaning Chamber2021-10-04 Replacement cleaning chamber packaged in plastic zip-lock bag.
00830002000056 - PuriLens Plus Disinfecting System Exchange Kit2021-10-04Exchange Kit contents: PuriLens Unit and removable cleaning/disinfecting chamber.
00830002000056 - PuriLens Plus Disinfecting System Exchange Kit2021-10-04 Exchange Kit contents: PuriLens Unit and removable cleaning/disinfecting chamber.
00830002000063 - PuriLens Plus Disinfecting System2021-10-04 Starter Kit contents: Electrical voltage adapter, PuriLens Unit, removable cleaning/disinfecting chamber, two 4-oz. (120-mL) bot
00830002000070 - PuriLens Plus Disinfecting System 110V Adapter2021-10-04 Replacement 110V Adapter packaged in plastic zip-lock bag.
00830002000094 - PuriLens Plus Preservative Free Saline2021-10-04 PuriLens Plus Preservative-Free Saline is a sterile, non-preserved, aqueous, isotonic solution of sodium chloride, buffered with
00830002001015 - SGP2018-07-06 Blanks (button blanks for use in the manufacture of RGP contact lenses) Color: Blue, Green, Brown, or Gray Number of Units

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