What is FDA product code FEB?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Gastroenterology & Urology › DiagnosticAccessories, Cleaning, For Endoscope

Good Bi-Brush

Name: Good Bi-Brush
Brand: Good Bi-Brush

A device used to remove dirt or debris from the working channel(s) of the endoscope prior to disinfection and sterilization. It consists of a flexible insertion tube with plastic bristles.…

Registry build 21.09.26

A device used to remove dirt or debris from the working channel(s) of the endoscope prior to disinfection and sterilization. It consists of a flexible insertion tube with plastic bristles. This is a single-use device.

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FEB
Manufacturer	City	Province	Registered as	Device types
Saint-Gobain Life Sciences (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	5

Record

Regulatory record for Good Bi-Brush
Listed by	Hobbs Medical, Inc., United States
FDA product code	FEB
Device type	Accessories, Cleaning, For Endoscope
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer
510(k)	K933354
Record published	2016-09-21
Record revised	2022-06-10 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Good Bi-Brush
Catalogue number	Size	Per pack	Status
4660		25	In distribution
4665		25	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medivators Hookup	Medivators Inc	333
Evotech™	Advanced Sterilization Products Services Inc.	104
Connecting Tube	Olympus Medical Systems Corp.	47
Accessories, Cleaning, For Endoscope	Steris Corporation	39
Accessories, Cleaning, For Endoscope	Pentax of America, Inc.	24
Accessories, Cleaning, For Endoscope	Richard Wolf Gmbh	16
ASP Aeroflex™	Advanced Sterilization Products Services Inc.	10
Scope Buddy Plus Tubing	Medivators Inc	9
Accessories, Cleaning, For Endoscope	Corporation Steris Canada	8
Scope Assist Flushing Sink (Safs)	Wassenburg Medical, Inc.	6
System 83 Plus	Wassenburg Medical, Inc.	4
Leak Test AIR Tube	Olympus Medical Systems Corp.	4

Showing 12 of 48. All products under Accessories, Cleaning, For Endoscope

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K933354	1993-10-28

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.