Hollister

Urinary Night Drainage Bag - STERILE Fluid Pathway

Registry build 21.09.26
23manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Zhejiang (5), Guangdong (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EYZ
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Anqing Kangmingna Packaging Co., Ltd. Anqing Anhui Contract manufacturer 39
Conod Medical Shuyang Co., Ltd. Shuyang Jiangsu Contract manufacturer 22
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Guangzhou Four E’s Scientific Co., Ltd. Guangzhou Guangdong Contract manufacturer 61
Jiangsu WLD Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 50
Anhui Medpurest Medical Technology Co., Ltd. Anqing Anhui Manufacturer 46
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44

Showing 12 of 23. All 23 manufacturers in China registered for System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile

Record

Regulatory record for Hollister
Listed by Hollister Incorporated, United States
FDA product code EYZ
Device type System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Device class Class 1
Regulation 21 CFR 876.5250
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-12-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Cas of 2, cas
Sizes Total volume 540 to 2000 ml

Catalogue Numbers

Catalogue numbers for Hollister
Catalogue number Size Per pack Status
9645 Total Volume 540 ml 10 In distribution
9655 Total Volume 900 ml 10 In distribution
9839 Total Volume 2000 ml 20 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medline Medline Industries, Inc. 5
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile Domico Med-Device, LLC 2
AMD-Ritmed AMD Medicom Inc. 2
Dover Cardinal Health 2
SmartTap™ Paracentesis Drainage Bag, 4L Cardiomed Supplies Inc 1
Endure Industries Endure Industries, Inc. 1
EZ-Flow Catheter Valve Flexicare Medical Ltd. 1
SmartTap™ Paracentesis Drainage Bag, 2L Cardiomed Supplies Inc 1

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