← Back to catalogue
Biotrue® Hydration Boost Contact Lens Rehydrating Drops
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Biotrue® Hydration Boost Contact Lens Rehydrating Drops FDA UDI
- Generic Name
- Contact lens wetting solution FDA UDI
- Device Name
- Preservative Free Lubricating and Rewetting Drops FDA UDI
- Model / Reference
- FCP-4371 FDA UDI
- Description
- Preservative Free Lubricating and Rewetting Drops FDA UDI
Identifiers
- Catalog Number
- 622249 FDA UDI
- Primary DI / UDI-DI
- 00310119022498 FDA UDI
- FDA Product Code
- LPN FDA UDIMRC FDA UDI
- GMDN Term
- Contact lens wetting solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5928 FDA UDI886.5918 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 wetting solution
Biotrue® Hydration Boost Contact Lens Rehydrating Drops by Bausch & Lomb Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Contact lens wetting solution.
- REFRESH CONTACTS® Contact Lens Comfort Drops — Allergan · Class II
- Nutrifill — CONTAMAC SOLUTIONS, INC. · Class II
- OPTI-FREE REPLENISH — Alcon Laboratories, Inc. · Class II
- LacriPure — MENICON AMERICA, INC. · Class II
- BLINK-N-CLEAN — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class II
- BLINK CONTACTS — Johnson & Johnson Surgical Vision, Inc. · Class II
- OPTI-FREE EXPRESS — Alcon Laboratories, Inc. · Class II
- Equate — Walmart Stores · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch & Lomb Incorporated
Sources (1)
- FDA UDI fb2555e4-bf36-4ec3-81e8-5da2ac488a21 34 fields · synced Jun 8, 2026