Cure Catheter
Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and gripper, Straight Tip
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.
| 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
| Listed by | Convatec, Purchasing Department |
|---|---|
| FDA product code | EZD |
| Device type | Catheter, Straight |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| 510(k) | K072539 |
| Record published | 2016-09-24 |
| Record revised | 2023-04-12 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 30, case of 10, case of 3 |
| Sizes | Catheter gauge 8 to 18 Fr; length 15 to 41 cm; length 10 to 16 in |
| Distribution end date | 2022-02-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M14UL | Catheter Gauge 14 Fr | In distribution |
| F10 | Length 15 cm | In distribution |
| P12 | Catheter Gauge 12 Fr | In distribution |
| M16U | Catheter Gauge 16 Fr | In distribution |
| M18C | Catheter Gauge 18 Fr | In distribution |
| HP14 | Catheter Gauge 14 Fr | In distribution |
| F12 | Catheter Gauge 12 Fr | In distribution |
| M12 | Catheter Gauge 12 Fr | In distribution |
| M10 | Catheter Gauge 10 Fr | In distribution |
| P10 | Catheter Gauge 10 Fr | In distribution |
| HM14C | Catheter Gauge 14 Fr | In distribution |
| HP10 | Catheter Gauge 10 Fr | In distribution |
| M16 | Catheter Gauge 16 Fr | In distribution |
| HM16C | Catheter Gauge 16 Fr | In distribution |
| F8 | Catheter Gauge 8 Fr | In distribution |
| M14U | Catheter Gauge 14 Fr | In distribution |
| M8 | Catheter Gauge 8 Fr | In distribution |
| F14NC | Catheter Gauge 14 Fr | In distribution |
| HM18C | Catheter Gauge 18 Fr | In distribution |
| F18 | Catheter Gauge 18 Fr | In distribution |
| M14UK | Catheter Gauge 14 Fr | In distribution |
| F14 | Catheter Gauge 14 Fr | In distribution |
| P8 | Catheter Gauge 8 Fr | In distribution |
| M12C | Catheter Gauge 12 Fr | In distribution |
| F16 | Catheter Gauge 16 Fr | In distribution |
| HM16 | Catheter Gauge 16 Fr | In distribution |
| HP8 | Catheter Gauge 8 Fr | In distribution |
| M10C | Catheter Gauge 10 Fr | In distribution |
| HP12 | Catheter Gauge 12 Fr | In distribution |
| HM14 | Catheter Gauge 14 Fr | In distribution |
| HM12C | Catheter Gauge 12 Fr | In distribution |
| M14 | Catheter Gauge 14 Fr | In distribution |
| M12U | Catheter Gauge 12 Fr | In distribution |
| P14 | Catheter Gauge 14 Fr | In distribution |
| M18 | Catheter Gauge 18 Fr | In distribution |
| HM12 | Catheter Gauge 12 Fr | In distribution |
| HM18 | Length 16 in | Withdrawn |
| P16 | Length 10 in | Withdrawn |
| HP16 | Length 10 in | Withdrawn |
Same 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 |
| 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cure Medical, LLC | 510(k) number | 2014-11-11 | Class II | Labeling mix-ups | Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter for bladder drainage, where P8 catheters | 192 cases = 1,920 boxes = 57,600 each | 2015-04-10 |
| Cure Medical, LLC | 510(k) number | 2012-09-19 | Class II | Labeling mix-ups | The firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coud-tip catheters while the actual contents are M16Fr male, 16Fr, straight-tip catheters with the pou | 420cases (= 4,200 boxes) | 2013-02-07 |
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.