Identity
- Trade Name
- Visine FDA UDI
- Generic Name
- Contact lens wetting solution FDA UDI
- Device Name
- Lubricating and Rewetting Drops for Contacts FDA UDI
- Model / Reference
- 00074300012537 FDA UDI
- Description
- Lubricating and Rewetting Drops for Contacts FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00074300012537 FDA UDI
- 510(k) Number
- K991620 FDA UDI
- FDA Product Code
- LPN FDA UDI
- GMDN Term
- Contact lens wetting solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5928 FDA UDI
- Commercial Distribution
- Not 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
Visine by Kenvue Brands LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Kenvue Brands LLC
Sources (1)
- FDA UDI b106ff71-ca51-4459-8bbc-6332faa90f76 37 fields · synced Jun 1, 2026