Medline
Tube, Endotracheal,cuff, Stylet, 7.0MM
9manufacturers in China registered for this device type
66catalogue numbers in this listing
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| 510(k) | K160694 |
| Record published | 2026-01-12 |
| Record revised | 2022-08-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Dry; Keep away from sunlight |
| Packaging | Box of 10, carton of 10, case of 10 |
| Sizes | Length 6 to 8.5 mm; lumen/inner diameter 3.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJAFLEX80 | In distribution | |
| DYNJAFLEX75 | In distribution | |
| DYNJAETC60 | Length 6 mm | In distribution |
| DYNJAFLEX70 | In distribution | |
| DYNJAETU45 | In distribution | |
| DYNJ18880NS | In distribution | |
| DYNJ18885 | Length 8.5 mm | In distribution |
| DYNJAETU30 | In distribution | |
| DYNJAETC75 | In distribution | |
| DYNJAETC35 | Lumen/Inner Diameter 3.5 mm | In distribution |
| DYNJAETC65 | In distribution | |
| DYNJAETC55 | In distribution | |
| DYNJAETC70 | In distribution | |
| DYNJAETC70S | In distribution | |
| DYNJAFLEXU60 | In distribution | |
| DYNJAETU50 | In distribution | |
| DYNJAFLEX50 | In distribution | |
| DYNJAETC80S | In distribution | |
| DYNJAFLEXU40 | In distribution | |
| DYNJAFLEXU65 | In distribution | |
| DYNJAETC95 | In distribution | |
| DYNJAETC40 | In distribution | |
| DYNJAFLEX40 | In distribution | |
| DYNJAETU55 | In distribution | |
| DYNJAFLEXU30 | In distribution | |
| DYNJ18865 | Length 6.5 mm | In distribution |
| DYNJ18860 | Length 6 mm | In distribution |
| DYNJAFLEX60 | In distribution | |
| DYNJAETU65 | In distribution | |
| DYNJ18875 | Length 7.5 mm | In distribution |
| DYNJAFLEX100 | In distribution | |
| DYNJAETC45 | In distribution | |
| DYNJAETC75S | In distribution | |
| DYNJAETC65S | In distribution | |
| DYNJAFLEX35 | In distribution | |
| DYNJAFLEX55 | In distribution | |
| DYNJAFLEX30 | In distribution | |
| DYNJAFLEXU55 | In distribution | |
| DYNJ18870 | Length 7 mm | In distribution |
| DYNJAETC80 | In distribution | |
| DYNJAETC85 | In distribution | |
| DYNJAETC50 | In distribution | |
| DYNJAETC90S | In distribution | |
| DYNJAFLEX25 | In distribution | |
| DYNJAFLEX45 | In distribution | |
| DYNJAETU40 | In distribution | |
| DYNJAFLEX65 | In distribution | |
| DYNJAETC85S | In distribution | |
| DYNJAETC60S | In distribution | |
| DYNJAFLEX85 | In distribution | |
| DYNJAETC95S | In distribution | |
| DYNJAFLEX95 | In distribution | |
| DYNJAFLEXU35 | In distribution | |
| DYNJAFLEXU20 | In distribution | |
| DYNJAETC50S | In distribution | |
| DYNJAETC55S | In distribution | |
| DYNJAETC90 | In distribution | |
| DYNJ18880 | Length 8 mm | In distribution |
| DYNJAFLEXU45 | In distribution | |
| HCSS4516HF | In distribution | |
| DYNJAETC30 | In distribution | |
| DYNJAFLEX90 | In distribution | |
| DYNJAETU60 | In distribution | |
| DYNJAFLEXU50 | In distribution | |
| DYNJAETU35 | In distribution | |
| DYNJAFLEXU25 | 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)
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| 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 | |
| Medline Industries, LP – Northfield | 510(k) number | 2024-02-26 | Class I | Under Investigation by firm | Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult | 168,632 tubes and 13,092 kits | |
| Parker Medical | 510(k) number | 2016-06-02 | Class II | Nonconforming Material/Component | Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes – (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use. | 5,500 units | 2017-01-31 |
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.