Aqua Naina Sterile Saline Solution

Basic Information

• Brand Name: Aqua Naina Sterile Saline Solution
• Primary DI: 00860005853410
• Version / Model: Sterile Saline Solution
• Company Name: Chemtex USA Inc.
• Labeler DUNS: 808358316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-20
• Public Version: 1
• Public Version Date: 2024-03-28
• Public Version Status: New
• Public Device Record Key: 5488266a-4fe6-45c3-bd10-ed77f32ef5b6

Device Description

The Aqua Naina Plus Sterile Saline Solution for single use is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses. The Aqua Naina Plus Sterile Saline Solution is indicated for single use following proper lens disinfection as recommended by the eye care practitioner.

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: Yes
• 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
60838	Contact lens rinsing solution	A sterile solution intended to be used to rinse debris or chemical agents from contact lenses (soft or rigid) prior to insertion; it may be intended to be used during storage or heat disinfection of contact lenses, or to dilute other contact lens solutions (e.g., contact lens protein-removal solution). It is an aqueous saline solution containing preservatives [e.g., edetate disodium (EDTA)] and buffering agents; it does not contain disinfecting, protein-removal, cleaning, or wetting agents. 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	00860005853410	GS1

Premarket Submissions

Submission Number	Supplement Number
K221263	000