Nutrifill

Basic Information

• Brand Name: Nutrifill
• Primary DI: 00850012123002
• Version / Model: Nutrifill
• Company Name: CONTAMAC SOLUTIONS, INC.
• Labeler DUNS: 117592637
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-20
• Public Version: 1
• Public Version Date: 2020-08-28
• Public Version Status: New
• Public Device Record Key: c2cb453e-e21c-49be-917c-5400b2bd7acf

Device Description

Ultra-Pure Nutrient Rich Specialty Lens Fill Solution

Device Characteristics

• Single Use: Yes
• 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

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	00850012123002	GS1
Package	10850012123009	GS1	box	12	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K181566	000