ASP Medical

Urine Collection BAG, 4L, Latex Free, 1/EA

Registry build 21.09.26
13manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (6), Guangdong (3), Jiangsu (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NNZ
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Changzhou DSB Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 16
Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. Hangzhou Zhejiang Contract manufacturer 15
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Chengdu Sichuan Contract manufacturer 10
Integral Medical Products Co., Ltd. Shaoxing Zhejiang Contract manufacturer 7
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Shandong Zhushi Pharmaceutical Group Co., Ltd. Heze Shandong Contract manufacturer 65
Ningbo Risenmed Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 42
K-MED Co., Ltd. Yangzhou Jiangsu Manufacturer 20
Excellentcare Medical (Huizhou) Ltd. Huizhou Guangdong Manufacturer 14
Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. Guangzhou Guangdong Contract manufacturer 14

Showing 12 of 13. All 13 manufacturers in China registered for System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile

Record

Regulatory record for ASP Medical
Listed by ASP Global, LLC, United States
FDA product code NNZ
Device type System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
Device class Class 1
Regulation 21 CFR 876.5250
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-04-15
Record revised 2022-06-10 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date
Packaging Case of 20

Catalogue Numbers

Catalogue numbers for ASP Medical
Catalogue number Size Status
UBT440 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hollister Hollister Incorporated 2
Leg Bag Holder Small Flexicare Medical Ltd. 1
Leg Bag Holder Large Flexicare Medical Ltd. 1
Leg Bag Holder Extra Large Flexicare Medical Ltd. 1
Cure Medical Convatec, Purchasing Department 1
Leg Bag Holder Medium Flexicare Medical Ltd. 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