Bausch + Lomb

Basic Information

• Brand Name: Bausch + Lomb
• Primary DI: 00310119035900
• Version / Model: 623590
• Catalog Number: FCP-4278A
• Company Name: Bausch & Lomb Incorporated
• Labeler DUNS: 196603781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-17
• Public Version: 1
• Public Version Date: 2019-01-17
• Public Version Status: New
• Public Device Record Key: bc4069c8-c817-4321-82a1-5629feaad4dd

Device Description

Soft Contact Lens Disinfecting Solution, Two 16 FL OZ Bottles, 2 Lens Cases

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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
LYL	Accessories, Solution, Ultrasonic Cleaners For Lenses	Ophthalmic	886.5928	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45870	Multi-purpose soft contact lens solution	A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting reusable soft contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00310119035900	GS1