Well Lead Endotracheal Tube
Endotracheal Tubes without Cuff (Oral/Nasal)10.0
9manufacturers in China registered for this device type
84catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Jiangxi Yikang Medical Instrument Group Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Qingdao Traworks Co., Ltd. | Qingdao | Shandong | Exporter | 7 |
| Tianjin Medis Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Chilecom Medical Devices Co Ltd | Xiangtan | Hunan | Manufacturer | 5 |
Record
| Listed by | Well Lead Medical Co., Ltd., China |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
| 510(k) | K042683 |
| Record published | 2024-03-27 |
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 |
| Packaging | Box of 10, carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A01A02553F | In distribution | |
| A01C01961F | In distribution | |
| A01A02203F | In distribution | |
| A01B02353F | In distribution | |
| A01A01751F | In distribution | |
| A01B02303F | In distribution | |
| A01A02703F | In distribution | |
| A01C01851F | In distribution | |
| A01C01801F | In distribution | |
| A01C02603F | In distribution | |
| A01B02853F | In distribution | |
| A01A02953F | In distribution | |
| A01A01651F | In distribution | |
| A01B02963F | In distribution | |
| A01A02753F | In distribution | |
| A01B02703F | In distribution | |
| A01B01601F | In distribution | |
| A01C01901F | In distribution | |
| A01A01501F | In distribution | |
| A01A02353F | In distribution | |
| A01C01751F | In distribution | |
| A01A02503F | In distribution | |
| A01B01901F | In distribution | |
| A01B01951F | In distribution | |
| A01B01651F | In distribution | |
| A01B02253F | In distribution | |
| A01C02803F | In distribution | |
| A01A02903F | In distribution | |
| A01C02203F | In distribution | |
| A01B02803F | In distribution | |
| A01C02553F | In distribution | |
| A01A02653F | In distribution | |
| A01B02653F | In distribution | |
| A01A01801F | In distribution | |
| A01B02203F | In distribution | |
| A01A02963F | In distribution | |
| A01C02963F | In distribution | |
| A01A02403F | In distribution | |
| A01C02953F | In distribution | |
| A01B02953F | In distribution | |
| A01B01701F | In distribution | |
| A01B01551F | In distribution | |
| A01A01961F | In distribution | |
| A01C01701F | In distribution | |
| A01A02453F | In distribution | |
| A01C02253F | In distribution | |
| A01B01851F | In distribution | |
| A01B02503F | In distribution | |
| A01C01951F | In distribution | |
| A01A01601F | In distribution | |
| A01B02453F | In distribution | |
| A01A02803F | In distribution | |
| A01C02353F | In distribution | |
| A01B01961F | In distribution | |
| A01B01751F | In distribution | |
| A01B02903F | In distribution | |
| A01C02453F | In distribution | |
| A01A02853F | In distribution | |
| A01A02253F | In distribution | |
| A01B02553F | In distribution | |
| A01C02403F | In distribution | |
| A01C02853F | In distribution | |
| A01A01851F | In distribution | |
| A01C02503F | In distribution | |
| A01C02653F | In distribution | |
| A01C01601F | In distribution | |
| A01A01551F | In distribution | |
| A01C02753F | In distribution | |
| A01B02753F | In distribution | |
| A01C01551F | In distribution | |
| A01B01501F | In distribution | |
| A01B02403F | In distribution | |
| A01A02303F | In distribution | |
| A01A01901F | In distribution | |
| A01A01951F | In distribution | |
| A01C02703F | In distribution | |
| A01C02303F | In distribution | |
| A01A01701F | In distribution | |
| A01B02603F | In distribution | |
| A01C01651F | In distribution | |
| A01C02903F | In distribution | |
| A01B01801F | In distribution | |
| A01C01501F | In distribution | |
| A01A02603F | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 301 |
| Shiley | Covidien LP | 295 |
| Mallinckrodt | Covidien LP | 258 |
| Hudson RCI | Teleflex Medical LLC | 241 |
| Portex | ICU Medical, Inc | 208 |
| Parker Flex-Tip | Salter Labs | 164 |
| Parker | Salter Labs | 157 |
| Curaplex | Bound Tree Medical, LLC | 149 |
| SourceMark | Sourcemark, LLC. | 148 |
| Montgomery® Safe-T-Tube™ | Boston Medical Products, Inc. | 144 |
| Sunmed | SunMed Group Holdings, LLC | 112 |
| Forsure | Forsure Medical Products LLC. | 101 |
Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211543 | 2022-07-21 |
| K182739 | 2019-12-11 |
| K110269 | 2011-08-26 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | 510(k) number | 2026-07-31 | Not classified | Process control | The 6Fr suction catheter could not pass through the samples smoothly. | 27200 |
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.