Aqua Naina Sterile Saline Solution

GUDID 00860005853410

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.

Chemtex USA Inc.

Contact lens rinsing solution

• Primary Device ID: 00860005853410
• NIH Device Record Key: 5488266a-4fe6-45c3-bd10-ed77f32ef5b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aqua Naina Sterile Saline Solution
• Version Model Number: Sterile Saline Solution
• Company DUNS: 808358316
• Company Name: Chemtex USA Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005853410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221263

FDA Product Code

• MRC: Products, Contact Lens Care, Rigid Gas Permeable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-28
• Device Publish Date: 2024-03-20