Kenorex
Endotracheal Tube Cuffed 7.0 MM With Suction Port Murphy EYE
9manufacturers in China registered for this device type
57catalogue 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 | Kentron Healthcare, Inc. |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| 510(k) | K042683 |
| Record published | 2016-09-10 |
| Record revised | 2020-06-19 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 769945 | In distribution | |
| 759920 | In distribution | |
| 769935 | In distribution | |
| 739960 | In distribution | |
| 739945 | In distribution | |
| 749980 | In distribution | |
| 739965 | In distribution | |
| 749970 | In distribution | |
| 749990 | In distribution | |
| 739940 | In distribution | |
| 769970 | In distribution | |
| 919970 | In distribution | |
| 749940 | In distribution | |
| 759930 | In distribution | |
| 919975 | In distribution | |
| 749945 | In distribution | |
| 769980 | In distribution | |
| 749955 | In distribution | |
| 739935 | In distribution | |
| 759925 | In distribution | |
| 919990 | In distribution | |
| 759965 | In distribution | |
| 769930 | In distribution | |
| 919960 | In distribution | |
| 739950 | In distribution | |
| 739955 | In distribution | |
| 769955 | In distribution | |
| 749960 | In distribution | |
| 749930 | In distribution | |
| 769990 | In distribution | |
| 749950 | In distribution | |
| 749935 | In distribution | |
| 769960 | In distribution | |
| 749100 | In distribution | |
| 769100 | In distribution | |
| 739920 | In distribution | |
| 739930 | In distribution | |
| 759935 | In distribution | |
| 769995 | In distribution | |
| 919965 | In distribution | |
| 759955 | In distribution | |
| 769965 | In distribution | |
| 919980 | In distribution | |
| 919985 | In distribution | |
| 739925 | In distribution | |
| 769950 | In distribution | |
| 769975 | In distribution | |
| 749995 | In distribution | |
| 759960 | In distribution | |
| 749975 | In distribution | |
| 759945 | In distribution | |
| 749985 | In distribution | |
| 769940 | In distribution | |
| 769985 | In distribution | |
| 759950 | In distribution | |
| 749965 | In distribution | |
| 759940 | 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.