What is FDA product code OCT?

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

Gastroenterology & Urology › DiagnosticAnti Fog Solution And Accessories, Endoscopy

Fog Guard Anti-Fog Solution With Sponge

Name: Fog Guard Anti-Fog Solution with Sponge
Brand: Fog Guard Anti-Fog Solution with Sponge

Catalogue number 30900, listed by Xodus Medical, Inc., United States, under Anti Fog Solution And Accessories, Endoscopy. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OCT
Manufacturer	City	Province	Registered as	Device types
Jianerkang Medical Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	18
Shenzhen Jingxintai Houseware Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6
Shanghai Xodus Medical Company Limited	Shanghai	Shanghai	Specification developer	25
Shanghai Lejoy Co., Ltd.	Shanghai	Shanghai	Exporter	21
Changzhou Atomic HI-Tech Radiation Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	8

Record

Regulatory record for Fog Guard Anti-Fog Solution with Sponge
Listed by	Xodus Medical, Inc., United States
FDA product code	OCT
Device type	Anti Fog Solution And Accessories, Endoscopy
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2017-03-28
Record revised	2023-01-20 (version 3)

Specifications

Specifications
MRI safety	MR Safe
Single use	Yes
Label carries	lot or batch number, serial number
Packaging	Pack of 20

Catalogue Numbers

Catalogue numbers for Fog Guard Anti-Fog Solution with Sponge
Catalogue number	Size	Status
30900		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Mr. Clear Purple	Mectra Labs, Inc.	8
DeRoyal	Deroyal Industries, Inc.	7
Dr. Fog® Treated Sponge	Aspen Surgical Products, Inc.	4
Dr. Fog® Solution With Sponge	Aspen Surgical Products, Inc.	2
Merocel® Elvis®	Medtronic Xomed, Inc.	2
Aspen® Anti-fog Solution	Aspen Surgical Products, Inc.	2
Dr. Fog® Anti-fog Solution	Aspen Surgical Products, Inc.	2
Richard Wolf	Mectra Labs, Inc.	2
Anti-fog w/Pad	Xodus Medical, Inc.	2
Merocel®	Medtronic Xomed, Inc.	2
Cardinal Health	Cardinal Health 200, LLC	2
Anti-Fog w/ Pad; in Tray	Xodus Medical, Inc.	2

Showing 12 of 41. All products under Anti Fog Solution And Accessories, Endoscopy

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K063587	2007-01-09

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.