PuriLens Plus Preservative Free Saline

Basic Information

• Brand Name: PuriLens Plus Preservative Free Saline
• Primary DI: 00830002000018
• Version / Model: 4 oz. (120 mL) Bottle
• Company Name: LIFESTYLE CO INC, THE
• Labeler DUNS: 946065000
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-24
• Public Version: 2
• Public Version Date: 2024-10-24
• Public Version Status: Update
• Public Device Record Key: 1704f026-b30f-49cf-b064-642884fcecc4

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).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	886.5918	2
LPN	Accessories, Soft Lens Products	Ophthalmic	886.5928	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60838	Contact lens rinsing solution	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00830002000087	GS1	3-pack carton	3	In Commercial Distribution
Primary	00830002000018	GS1
Package	00830002000025	GS1	12-pack carton	12	In Commercial Distribution
Package	00830002000124	GS1	6-pack carton	6	In Commercial Distribution

Customer Contacts

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