Fred 2

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Fred 2 FDA UDI
Generic Name: Endoscope antifog solution FDA UDI
Device Name: Anti-Fog Kit FDA UDI
Model / Reference: 220-50 FDA UDI
Description: Anti-Fog Kit FDA UDI

Identifiers

Primary DI / UDI-DI: 20884521066547 FDA UDI
510(k) Number: K923843 FDA UDI
FDA Product Code: HET FDA UDI
GMDN Term: Endoscope antifog solution FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1720 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Endoscope antifog solution

Fred 2 by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Endoscope antifog solution.

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Devon — Cardinalhealth · Class II
DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
ArcRoyal Anti-Fog, Regular Solution, Sterile — Aspen Surgical Products, Inc. · Class II
Anti-Fog w/ Pad — XODUS MEDICAL, INC. · Class II
Dr. Fog® Treated Sponge — Aspen Surgical Products, Inc. · Class II

Cleared under the same submission

K923843 also covers:

Fred — Covidien LP

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: Covidien LP

Sources (1)

FDA UDI 70239f4c-cc64-4e38-888f-ced088d464d7 36 fields · synced Jun 6, 2026