Identity
- Trade Name
- Regard™ FDA UDI
- Generic Name
- Endoscope antifog solution FDA UDI
- Model / Reference
- 243453 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20326053104309 FDA UDI
- 510(k) Number
- K080189 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Endoscope antifog solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Endoscope antifog solution
Regard™ by Resource Optimization & Innovation, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope antifog solution.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Flo-X — Minimally Invasive Devices, LLC · Class II
- ClearIt Anti-Fog Kit — PRESERVATION SOLUTIONS, INC. · Class II
- Devon — Cardinalhealth · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- ArcRoyal Anti-Fog, Regular Solution, Sterile — Aspen Surgical Products, Inc. · Class II
- Clearify — Covidien LP · Class II
- Anti-Fog w/ Pad — XODUS MEDICAL, INC. · Class II
Cleared under the same submission
K080189 also covers:
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
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
- Resource Optimization & Innovation, L.l.c.
Sources (1)
- FDA UDI 1fb9bb23-b17c-4824-bcdf-ecec17e47183 33 fields · synced May 30, 2026