FDA UDI
In Commercial Distribution
🇺🇸 United States
Vista Clean Multi-Purpose Solution
DI: 00351801021016
·
Model: A
·
Nomax, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Vista Clean Multi-Purpose Solution
- Primary DI
- 00351801021016
- Version / Model
- A
- Catalog Number
- AH-3664-00000
- Company Name
- Nomax, Inc.
- Labeler DUNS
- 103220273
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-06
- Public Version
- 2
- Public Version Date
- 2024-11-11
- Public Version Status
- Update
- Public Device Record Key
- 6b8cb9ab-4386-4a99-bd95-2892d6be6e14
Device Description
Vista Clean multi-purpose contact lens solution cleans, rinses, disinfects, stores, and conditions contact lenses. Vista Clean is compatible for use with any lens type including RGP lenses, scleral lenses, hybrid lenses, and soft lenses including silicone hydrogel.
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
- 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 |
|---|---|---|---|---|
| LPN | Accessories, Soft Lens Products | Ophthalmic | 886.5928 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48074 | Multi-purpose soft/rigid contact lens solution | A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting soft contact lenses and rigid gas permeable (RGP)/hard 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 |
| 48075 | Multi-purpose rigid contact lens solution | A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting rigid gas permeable (RGP) and hard 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 | 00351801021016 | GS1 | ||||
| Package | 00351801021023 | GS1 | Case | 32 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-255-6161
- [email protected]