Argo Bagz Fluid Management Systems

5 catalogue numbers from 197540, listed by Argon Medical Devices, Inc., United States, under Injector And Syringe, Angiographic. 15 manufacturers in China are registered for this product code.

Registry build 21.09.26
15manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (7), Jiangsu (3), Shandong (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DXT
Manufacturer City Province Registered as Device types
Changzhou DSB Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 16
Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. Hangzhou Zhejiang Contract manufacturer 15
Sunny Medical Device (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
ShanDong WeiGao Group Medical Polymer Co., Ltd. Weihai Shandong Contract manufacturer 3
Jiangxi Baoeran Biomedical Science & Technology Co., Ltd. Fuzhou Jiangxi Contract manufacturer 1
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Wuxi Yushou Medical Appliances Co., Ltd. Wuxi Jiangsu Contract manufacturer 8
Shandong INT Medical Instruments Co., Ltd. Rizhao Shandong Manufacturer 4
Zhuhai DR Medical Instruments Co., Ltd. Zhuhai Guangdong Manufacturer 4
Shenzhen Antmed Co., Ltd. Dongguan Guangdong Manufacturer 4

Showing 12 of 15. All 15 manufacturers in China registered for Injector And Syringe, Angiographic

Record

Regulatory record for Argo Bagz Fluid Management Systems
Listed by Argon Medical Devices, Inc., United States
FDA product code DXT
Device type Injector And Syringe, Angiographic
Device class Class 2
Regulation 21 CFR 870.1650
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
510(k) K904994
Record published 2016-08-26
Record revised 2026-05-11 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 20
Distribution end date 2024-12-09

Catalogue Numbers

Catalogue numbers for Argo Bagz Fluid Management Systems
Catalogue number Size Status
197540 In distribution
197611 In distribution
197580 In distribution
197590 Withdrawn
197560 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sinton Medical Products Shenzhen Boon Medical Supply Co., Ltd. 199
DeRoyal Deroyal Industries, Inc. 138
Antmed Shenzhen Antmed Co., Ltd. 91
Medline Industries, Inc. Medline Industries, Inc. 59
LF Liebel-Flarsheim Company LLC 58
Namic Medline Industries, Inc. 50
Merit Medical® Merit Medical Systems, Inc. 46
Medical Imaging Solutions International Shenzhen Boon Medical Supply Co., Ltd. 43
LF Shenzhen Boon Medical Supply Co., Ltd. 38
Namic Navilyst Medical, Inc. 38
Coeur Coeur, Inc. 38
Medical Imaging Solutions Intl. Medical Imaging Solutions, Inc. 37

Showing 12 of 168. All products under Injector And Syringe, Angiographic

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