ICU Medical, Inc.

GTIN for 011-BICSWB, 10/EA

Registry build 21.09.26
26manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (9), Guangdong (6), Zhejiang (5). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EPE
Manufacturer City Province Registered as Device types
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Jiangsu Huadong Medical Device Industry Co., Ltd. Yangzhou Jiangsu Contract manufacturer 29
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23
Medico Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Shanghai Like Brush Co., Ltd. Xuancheng Anhui Contract manufacturer 1
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huanghua Promisee Dental Co., Ltd. Huanghua Hebei Manufacturer 54
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Suzhou Texnet Suzhou Jiangsu Contract manufacturer 47

Showing 12 of 26. All 26 manufacturers in China registered for Brush, Cleaning, Tracheal Tube

Record

Regulatory record for ICU Medical, Inc.
Listed by ICU Medical, Inc, United States
FDA product code EPE
Device type Brush, Cleaning, Tracheal Tube
Device class Class 1
Regulation 21 CFR 868.5795
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2026-06-25

Specifications

Specifications
MRI safety MR Safe
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Packaging Case of 3, pallet of 20

Catalogue Numbers

Catalogue numbers for ICU Medical, Inc.
Catalogue number Size Status
011-BICSWB In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
InHealth Technologies; Blom-Singer; Classic Freudenberg Medical, LLC 37
Tracoe® care Tracoe Medical Gmbh 9
InHealth Technologies; Blom-Singer; Advantage Freudenberg Medical, LLC 9
Trach Tube Cleaning Brushes Boston Medical Products, Inc. 8
InHealth Technologies; Blom-Singer; Dual Valve Freudenberg Medical, LLC 6
Grafco GF Health Products, Inc 4
Pilling Teleflex Medical LLC 4
InHealth Technologies; Blom-Singer Freudenberg Medical, LLC 3
XinjingProWellness™ Tianjin Newtrans Technology Development 3
Sklar Sklar Corporation 3
AincA® Anesthesia Associates, Inc. 3
Bioseal Inc. Bioseal 2

Showing 12 of 29. All products under Brush, Cleaning, Tracheal Tube

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer