Customed
Suction Catheter 16FR
70manufacturers in China registered for this device type
7catalogue numbers in this listing
2recalls on this code
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 | Customed, Inc., United States |
|---|---|
| FDA product code | JOL |
| Device type | Catheter And Tip, Suction |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2020-04-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Avoid excessive heat and direct sunlight.; Special storage condition: Store in a clean, fresh, dry place. |
| Packaging | 100/box, 10box/cs of 10, 100/box of 100, 10/box of 100, 100/box,10box/cs of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 152570148316 | 16 FR | In distribution |
| 152570148318 | 18 FR | In distribution |
| 152570148308 | 8 FR | In distribution |
| 152570148310 | 10 FR | In distribution |
| 152570148306 | 6 FR | In distribution |
| 152570148314 | 14 FR | In distribution |
| 152570148312 | 12 FR | 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
2 of these are 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 |
|---|---|---|---|---|---|
| 2016-01-07 | Class II | Packaging | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | 5650 | 2017-05-03 |
| 2015-07-10 | Class II | Packaging | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. | 8300 | 2017-04-12 |
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.