TruCath

TruCath® Drainage Bag, 4,000 ml Drip Chamber, Metal-Clamp Drainage, Luer Lock Sample Port, 48" of Tubing, Bed-Sheet Clamp, Universal Hanger, Tyvek Pouch, Sterile

Registry build 21.09.26
51manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (25), Zhejiang (9), Shanghai (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KNX
Manufacturer City Province Registered as Device types
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Suzhou Jingle Polymer Medical Apparatus Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Sino Protection (Hefei) Medical Products Co., Ltd. Hefei Anhui Contract manufacturer 18
Hitec Medical Co., Ltd. Shanghai Shanghai Contract manufacturer 17
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
Heyuan Hong DE Medical Products Co., Ltd. Heyuan Guangdong Contract manufacturer 13
Meifu Medical Technology Suzhou Co., Ltd. Suzhou Jiangsu Contract manufacturer 13
Primecare Medical (Huzhou) Co., Ltd. Hu Zhou Zhejiang Contract manufacturer 9
Anhui Careplus Medical Technology Co., Ltd. Xuancheng Anhui Contract manufacturer 6
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129

Showing 12 of 51. All 51 manufacturers in China registered for Collector, Urine, (And Accessories) For Indwelling Catheter

Record

Regulatory record for TruCath
Listed by HR Pharmaceuticals Inc.
FDA product code KNX
Device type Collector, Urine, (And Accessories) For Indwelling Catheter
Device class Class 2
Regulation 21 CFR 876.5250
Premarket notification Exempt
Record published 2025-02-17

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Case of 20, case of 10

Catalogue Numbers

Catalogue numbers for TruCath
Catalogue number Size Status
HRDB4000 In distribution
HRDB2000 In distribution
HRNB2000 In distribution
HRUM2500 In distribution
HRNB4000 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Dover Cardinal Health 71
Urine Bag Well Lead Medical Co., Ltd. 64
Dover Cardinal Health 200, LLC 53
Medline Medline Industries, Inc. 19
Rusch Teleflex Medical LLC 10
Bard® Urine Meter with Bag C.R. Bard, Inc. 10
Bard® Add-A-Foley Tray C.R. Bard, Inc. 10
AMSure® Urinary Drainage Bag Amsino Medical Inc. 8
Bard® Urinary Drainage Bag with Anti-Reflux Chamber C.R. Bard, Inc. 6
Bard® Urinary Drainage Bag C.R. Bard, Inc. 6
Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) Urocare Products, Inc. 6
Medline Industries, Inc. Medline Industries, Inc. 5

Showing 12 of 113. All products under Collector, Urine, (And Accessories) For Indwelling Catheter

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