PuriLens Plus Disinfecting System Exchange Kit

Basic Information

• Brand Name: PuriLens Plus Disinfecting System Exchange Kit
• Primary DI: 00830002000056
• Version / Model: MS0610/H
• Company Name: LIFESTYLE CO INC, THE
• Labeler DUNS: 946065000
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-24
• Public Version: 2
• Public Version Date: 2023-06-16
• Public Version Status: Update
• Public Device Record Key: b2fd4811-f6bc-4398-b54c-93f3fa833f57
• Distribution End Date: 2021-12-31

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYL	Accessories, Solution, Ultrasonic Cleaners For Lenses	Ophthalmic	886.5928	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45872	Contact lens agitation cleaning system, mechanical	An assembly of devices used to clean and disinfect contact lenses through automated or manual mechanical agitation (e.g., spinning, shaking, wiping). It may consist of a reservoir to hold contact lens solution and the lenses, a base, a cap, and additional components, however other configurations are possible. Some assemblies may include an ultraviolet (UV) radiation source.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00830002000056	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]