Biotrue® Hydration Boost Contact Lens Rehydrating Drops

Basic Information

• Brand Name: Biotrue® Hydration Boost Contact Lens Rehydrating Drops
• Primary DI: 00310119022771
• Version / Model: FCP-4371
• Catalog Number: 622277BO
• Company Name: Bausch & Lomb Incorporated
• Labeler DUNS: 196603781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-25
• Public Version: 1
• Public Version Date: 2023-11-02
• Public Version Status: New
• Public Device Record Key: a7c6fa07-1c9a-442a-8105-683cf066343c

Device Description

Preservative Free Lubricating and Rewetting Drops for Contact Lens

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
LPN	Accessories, Soft Lens Products	Ophthalmic	886.5928	2
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	886.5918	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48082	Contact lens wetting solution	An aqueous formulation intended to wet contact lenses. The device is dispensed as droplets typically directly on the eyes while the patient wears the contact lenses; it is available in single- or multiple-dose containers. 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	00310119022771	GS1