REFRESH CONTACTS® Contact Lens Comfort Drops

Basic Information

• Brand Name: REFRESH CONTACTS® Contact Lens Comfort Drops
• Primary DI: 00300231822120
• Version / Model: 91822US
• Catalog Number: 91822US
• Company Name: Allergan, Inc.
• Labeler DUNS: 144796497
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-09
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d33f9108-c861-49f5-b132-d71480378921

Device Description

REFRESH CONTACTS® Contact Lens Comfort Drops

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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

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	00300231822120	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992028	000