Identity
- Trade Name
- Aqua Naina Sterile Saline Solution FDA UDI
- Generic Name
- Contact lens rinsing solution FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Sterile Saline Solution FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005853410 FDA UDI
- 510(k) Number
- K221263 FDA UDI
- FDA Product Code
- MRC FDA UDI
- GMDN Term
- Contact lens rinsing solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5918 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Contact lens rinsing solution
Aqua Naina Sterile Saline Solution by Chemtex USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Chemtex USA, Inc.
Sources (1)
- FDA UDI 5488266a-4fe6-45c3-bd10-ed77f32ef5b6 34 fields · synced May 30, 2026