Hi-Slip® Plus

Single Use Hydrophilic Urinary Catheter With Water Sachet Pediatric 12" 08FR

Registry build 21.09.26
21manufacturers in China registered for this device type
31catalogue 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 hi-slip® plus
Listed by Oasis Medikal Urunler Kimya Turizm Sanayi VE Ticaret Anonim Sirketi
FDA product code EZD
Device type Catheter, Straight
Device class Class 2
Regulation 21 CFR 876.5130
Record published 2016-09-23
Record revised 2022-12-23 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date
Storage Special storage condition: Keep dry and keep away from sunlight
Packaging Pack of 30, pack of 4
Sizes Catheter gauge 6 to 24 Fr; length 6 to 16 in
Distribution end date 2022-08-01
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for hi-slip® plus
Catalogue number Size Status
HS.PF1518 Catheter Gauge 18 Fr Withdrawn
HS.PM4020 Length 16 in Withdrawn
HS.PM4014 Catheter Gauge 14 Fr Withdrawn
HS.PM4010 Catheter Gauge 10 Fr Withdrawn
HS.PM4024 Catheter Gauge 24 Fr Withdrawn
HS.PF1516 Length 6 in Withdrawn
HS.PF2016 Length 8 in Withdrawn
HS.PF2014 Catheter Gauge 14 Fr Withdrawn
HS.PT4014 Length 16 in Withdrawn
HS.PF2010 Length 8 in Withdrawn
HS.PF2008 Catheter Gauge 8 Fr Withdrawn
HS.PF2012 Length 8 in Withdrawn
HS.PF2018 Length 8 in Withdrawn
HS.PM4008 Catheter Gauge 8 Fr Withdrawn
HS.PP3008 Catheter Gauge 8 Fr Withdrawn
HS.PM4022 Catheter Gauge 22 Fr Withdrawn
HS.PT4010 Length 16 in Withdrawn
HS.PF1512 Catheter Gauge 12 Fr Withdrawn
HS.PF1510 Length 6 in Withdrawn
HS.PF1514 Catheter Gauge 14 Fr Withdrawn
HS.PP3010 Catheter Gauge 10 Fr Withdrawn
HS.PT4012 Length 16 in Withdrawn
HS.PT4020 Catheter Gauge 20 Fr Withdrawn
HS.PP3006 Catheter Gauge 6 Fr Withdrawn
HS.PM4016 Catheter Gauge 16 Fr Withdrawn
HS.PM4012 Catheter Gauge 12 Fr Withdrawn
HS.PP2006 Length 8 in Withdrawn
HS.PM4018 Catheter Gauge 18 Fr Withdrawn
HS.PT4016 Length 16 in Withdrawn
HS.PT4018 Length 16 in Withdrawn
HS.PF1508 Catheter Gauge 8 Fr Withdrawn

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
Halyard Owens & Minor Distribution, Inc. 39
Cure Catheter Convatec, Purchasing Department 39
AMSure® PVC Intermittent Catheter Amsino Medical Inc. 39
LoFric® Origo™ Wellspect Healthcare 34

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