Arrow
Arrow-Clarke(TM) Pleura-Seal(R) Thoracentesis Kit with Sharps Safety Features
70manufacturers in China registered for this device type
38catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (22), Zhejiang (20), Guangdong (10). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Showing 12 of 70. All 70 manufacturers in China registered for Catheter And Tip, Suction
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | JOL |
| Device type | Catheter And Tip, Suction |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K870572 |
| Record published | 2019-07-09 |
| Record revised | 2024-02-14 (version 9) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 10, case of 5, case of 6, peel pack of 10 |
| Sizes | Catheter gauge 8 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN039807 | Catheter Gauge 8 Fr | In distribution |
| IPN033837 | In distribution | |
| IPN034163 | In distribution | |
| IPN039282 | Catheter Gauge 8 Fr | In distribution |
| IPN924876 | In distribution | |
| IPN036831 | In distribution | |
| IPN039281 | Catheter Gauge 8 Fr | In distribution |
| IPN032615 | In distribution | |
| IPN039728 | Catheter Gauge 8 Fr | In distribution |
| IPN039806 | Catheter Gauge 8 Fr | In distribution |
| IPN033838 | In distribution | |
| IPN037017 | In distribution | |
| IPN032615 | In distribution | |
| IPN038623 | Catheter Gauge 8 Fr | In distribution |
| IPN032600 | In distribution | |
| IPN033012 | In distribution | |
| IPN039280 | Catheter Gauge 8 Fr | In distribution |
| IPN037017 | In distribution | |
| IPN033838 | In distribution | |
| IPN036831 | In distribution | |
| IPN032616 | In distribution | |
| IPN037088 | In distribution | |
| IPN036977 | In distribution | |
| IPN032599 | In distribution | |
| IPN034170 | In distribution | |
| IPN036831 | In distribution | |
| IPN922898 | In distribution | |
| IPN033838 | In distribution | |
| IPN033011 | In distribution | |
| IPN920356 | In distribution | |
| IPN036977 | In distribution | |
| IPN034166 | In distribution | |
| IPN920804 | In distribution | |
| IPN036543 | In distribution | |
| IPN032616 | In distribution | |
| IPN924881 | In distribution | |
| IPN034166 | In distribution | |
| IPN037088 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 679 |
| Gen2 | Surgix Medical LLC | 497 |
| Avalign | Avalign Technologies, Inc. | 459 |
| Ambler Surgical | Ambler Surgical, LLC | 369 |
| Surtex | Surtex Instruments Ltd | 282 |
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 281 |
| V. Mueller | Steris Corporation | 230 |
| Liposuction Cannula | Sontec Instruments, Inc. | 159 |
| Pilling | Teleflex Medical LLC | 135 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 127 |
| Argyle | Cardinal Health 200, LLC | 125 |
| Argyle | Cardinal Health | 117 |
Showing 12 of 397. All products under Catheter And Tip, Suction
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-01-07 | Class II | Nonconforming Material/Component | The internal tip is missing from the device, causing the device to not function as intended. | 80 units | 2021-11-04 |
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.