Medline
Yankauer,bulb Tip,on/OFF Control,sterile
70manufacturers in China registered for this device type
35catalogue numbers in this listing
1510(k) clearance
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | JOL |
| Device type | Catheter And Tip, Suction |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Premarket notification | Exempt |
| Record published | 2021-01-02 |
| Record revised | 2025-06-13 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Avoid excessive heat. Protect from freezing. |
| Packaging | Case of 50, case of 36, case of 100, pack of 100 |
| Sizes | Catheter gauge 10 to 18 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| OR87TRG | In distribution | ||
| DYND41904C | Catheter Gauge 18 Fr | In distribution | |
| OR164 | In distribution | ||
| MDS0876628 | In distribution | ||
| OR80 | In distribution | ||
| MDS096575 | 100 | In distribution | |
| DYND41478 | In distribution | ||
| DYND50140 | In distribution | ||
| OR87V | In distribution | ||
| DYNDJ1070 | In distribution | ||
| DYNDFR18S | In distribution | ||
| DYND41900 | CATHETER GAUGE: 10 FRENCH | In distribution | |
| OR80V | In distribution | ||
| DYND41471 | In distribution | ||
| MDS876629 | In distribution | ||
| MDG0289891 | In distribution | ||
| MDS096204P | In distribution | ||
| MDG0267604 | In distribution | ||
| DYND52132 | In distribution | ||
| DYND41474 | In distribution | ||
| DYND41476 | In distribution | ||
| DYND41902C | CATHETER GAUGE: 14 FRENCH | In distribution | |
| OR61V | In distribution | ||
| MDG1113651 | In distribution | ||
| MDS096525 | 100 | In distribution | |
| DYND50180 | In distribution | ||
| DYND52130 | In distribution | ||
| MDS1201401 | In distribution | ||
| DYND50142 | In distribution | ||
| DYND41470 | In distribution | ||
| MDS096640 | In distribution | ||
| MDS876635TP | In distribution | ||
| DYND50130 | In distribution | ||
| DYND50143 | In distribution | ||
| DYND48982 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K943773 | 1995-02-27 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | 1,012,700 units |
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.