Argyle

Penrose Tubing Radiopaque

Registry build 21.09.26
33manufacturers in China registered for this device type
16catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (18), Zhejiang (9), Guangdong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KGZ
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Conod Medical Shuyang Co., Ltd. Shuyang Jiangsu Contract manufacturer 22
Changzhou DSB Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 16
Alleva Medical (D.G.) Ltd Dongguan Guangdong Contract manufacturer 13
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
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62

Showing 12 of 33. All 33 manufacturers in China registered for Accessories, Catheter

Record

Regulatory record for Argyle
Listed by Cardinal Health, United States
FDA product code KGZ
Device type Accessories, Catheter
Device class Class 1
Regulation 21 CFR 878.4200
Establishment Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2018-06-27
Record revised 2024-01-01 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Over the counter Yes
Latex Contains natural rubber latex
Label carries lot or batch number
Storage Special storage condition: ;
Packaging Case of 50, case of 500, pack_or_inner_pack of 50, case of 10
Sizes Outer diameter 0.25 to 1 in; length 12 to 18 in; height 0.4375 to 1.5 in
Distribution end date 2023-12-31

Catalogue Numbers

Catalogue numbers for Argyle
Catalogue number Size Status
8888513408 Outer Diameter 0.375 in In distribution
8888513200 Outer Diameter 0.3125 in Withdrawn
8888513002 Outer Diameter 0.25 in Withdrawn
8888513606 Length 12 in Withdrawn
8888515205 Length 18 in Withdrawn
8888515007 Outer Diameter 0.375 in Withdrawn
8888515601 Outer Diameter 0.75 in Withdrawn
8888513804 Outer Diameter 0.625 in Withdrawn
8888514208 Length 12 in Withdrawn
8888514604 Length 18 in Withdrawn
8888515809 Withdrawn
8888515403 Height 1 in Withdrawn
8888515809 Withdrawn
8888514000 Length 12 in Withdrawn
8888514802 Length 18 in Withdrawn
8888514406 Height 1.50 in Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MedDrain Armm, Inc. 77
Silicone Drainage Tube Fortune Medical Instrument Corp. 74
Typenex Wound Drainage Typenex Medical, LLC 56
Cook Cook Incorporated 49
Marina Medical Marina Medical Instruments, Inc. 48
Curaplex Bound Tree Medical, LLC 36
Mediplus Mediplus Ltd. 29
AlliedSil™ Silicone Tubing Implantech Associates, Inc. 24
Arrow Teleflex Medical LLC 23
Silicone Thoracic Catheters Atrium Medical Corporation 21
Neff Cook Incorporated 18
Silhouette Cook Incorporated 16

Showing 12 of 111. All products under Accessories, 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