Halyard

Intermittent Hydrophilic Catheter Pedriatric Polyacrylamide coating 14FR 10IN PVC CLEAR CA/300 NOT MADE WITH NATURAL RUBBER LATEX Halyard

Registry build 21.09.26
21manufacturers in China registered for this device type
39catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (9), Zhejiang (7), Shanghai (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EZD
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Conod Medical Shuyang Co., Ltd. Shuyang Jiangsu Contract manufacturer 22
Suzhou Jingle Polymer Medical Apparatus Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Haiyan Kangyuan Medical Instrument Co., Ltd. Jiaxing Zhejiang Contract manufacturer 17
Jiangsu Suyun Medical Materials Co., Ltd. Lianyungang Jiangsu Contract manufacturer 11
Integral Medical Products Co., Ltd. Shaoxing Zhejiang Contract manufacturer 7
Shaoxing Fuqing Health Products Co., Ltd. Shaoxing Zhejiang Contract manufacturer 3
Xianju Bever Medical Devices Co., Ltd. Taizhou Zhejiang Contract manufacturer 3
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43

Showing 12 of 21. All 21 manufacturers in China registered for Catheter, Straight

Record

Regulatory record for Halyard
Listed by Owens & Minor Distribution, Inc.
FDA product code EZD
Device type Catheter, Straight
Device class Class 2
Regulation 21 CFR 876.5130
510(k) K220722
Record published 2025-01-29

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Pack of 100, pack of 6, pack of 30, pack of 10
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Halyard
Catalogue number Size Status
55793 In distribution
55801 In distribution
55783 In distribution
55812 In distribution
55806 In distribution
55810 In distribution
55791 In distribution
55795 In distribution
55800 In distribution
55807 In distribution
55786 In distribution
55808 In distribution
55802 In distribution
55768 In distribution
55811 In distribution
55771 In distribution
55805 In distribution
55762 In distribution
55798 In distribution
55788 In distribution
55794 In distribution
55779 In distribution
55773 In distribution
55756 In distribution
55813 In distribution
55774 In distribution
55789 In distribution
55757 In distribution
55804 In distribution
55797 In distribution
55784 In distribution
55769 In distribution
55753 In distribution
55750 In distribution
55763 In distribution
55765 In distribution
55761 In distribution
55809 In distribution
55766 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Disposable intermittent catheter (TPU Catheter) Chengdu Daxan Innovative Medical Tech. Co., Ltd. 140
LoFric® Hydro-Kit™ Wellspect Healthcare 57
LoFric® Wellspect Healthcare 56
SimPro™ Now Wellspect Healthcare 55
Self-Cath Coloplast A/S 50
Wellead PVC Hydrophilic Urethral Catheter Well Lead Medical Co., Ltd. 50
LoFric® Primo™ Wellspect Healthcare 48
Medline Medline Industries, Inc. 47
Cure Catheter Convatec, Purchasing Department 39
AMSure® PVC Intermittent Catheter Amsino Medical Inc. 39
LoFric® Origo™ Wellspect Healthcare 34
PVC Hydrophilic Urethral Catheter Chengdu Daxan Innovative Medical Tech. Co., Ltd. 32

Showing 12 of 72. All products under Catheter, Straight

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