Endotracheal Tube With Evacuation Lumen
This Endotracheal Tube with Evacuation Lumen supports oral intubation and drainage of secretions above the cuff. A main lumen provides ventilation, while two smaller channels in the wall…
This Endotracheal Tube with Evacuation Lumen supports oral intubation and drainage of secretions above the cuff. A main lumen provides ventilation, while two smaller channels in the wall handle cuff inflation and subglottic suction. The tube has a Magill curve and a standard 15 mm connector.
The low-pressure cylindrical cuff is inflated with air through a pilot balloon and nonreturn valve. A separate capped suction connector attaches to hospital vacuum equipment. A radiopaque line supports X-ray visualization. The documented range includes internal diameters from 6.0 to 9.0 mm.
Listed Item
PVC DEHP Free Cuff 9.0
Materials and Supply
The modified PVC components are made without DEHP, including the main tube, inflation tube, suction line and pilot balloon. Cuff options are DEHP-free PVC or polyurethane. Tubes are supplied sterile for single use, with cuff material depending on the selected configuration.
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) | K182739 |
| Record published | 2024-01-27 |
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 |
|---|---|---|
| A01F01901F | In distribution | |
| A01G04754F | In distribution | |
| A01G04904F | In distribution | |
| A01G04854F | In distribution | |
| A01F01701F | In distribution | |
| A01F01651F | In distribution | |
| A01F01751F | In distribution | |
| A01F01851F | In distribution | |
| A01G04704F | In distribution | |
| A01F01801F | In distribution | |
| A01G04604F | In distribution | |
| A01G04804F | In distribution | |
| A01F01601F | In distribution | |
| A01G04654F | 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
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 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.