Nightengale
Nightengale Pneumothorax Set
70manufacturers in China registered for this device type
1catalogue number
3recalls 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 | Cook Incorporated, United States |
|---|---|
| FDA product code | JOL |
| Device type | Catheter And Tip, Suction |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2024-01-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G05282 | 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
3 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 |
|---|---|---|---|---|---|
| 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 318 units | |
| 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 104 units | |
| 2019-09-17 | Class II | Under Investigation by firm | Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device. | 41 units | 2020-05-21 |
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.