HydroPure

Basic Information

• Brand Name: HydroPure
• Primary DI: 00606492119086
• Version / Model: 1
• Company Name: Ote North America LLC
• Labeler DUNS: 963905034
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-10
• Public Version: 1
• Public Version Date: 2024-07-18
• Public Version Status: New
• Public Device Record Key: 0aa6c89f-0f8f-474a-96db-d5c959948734

Device Description

HydroPure Multi-Purpose contact lens cleaning solution 12 fl oz.

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: Yes
• 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

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	00606492119086	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 55 – 77 Degrees Fahrenheit