Tenax Laser Resistant Endotracheal Tube
Tenax is a laser-resistant endotracheal tube for adults undergoing upper gastro-respiratory laser surgery. It provides the airway for intubation in procedures using carbon-dioxide or KTP…
Tenax is a laser-resistant endotracheal tube for adults undergoing upper gastro-respiratory laser surgery. It provides the airway for intubation in procedures using carbon-dioxide or KTP lasers.
The tube has two inflatable cuffs, an inner aluminum scattering layer for laser resistance and an outer tissue-contact layer. Internal dye provides a visible warning of puncture or device damage.
Listed Item
Tenax Laser Resistant Endotracheal Tube 7.0mm I.D. x 10.6mm O.D. (32FR)
Laser and Supply Scope
The specified lasers are CO2 at 10.60 microns and KTP at 532 nm, with noncontact pulsed or continuous delivery. The intended population is adults aged 22 or older. The tube is supplied ethylene-oxide-sterilized and discarded after use.
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 | Bryan Medical Inc., United States |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K200761 |
| Record published | 2020-12-18 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TG0055 | In distribution | |
| TG0050 | In distribution | |
| TG0060 | In distribution | |
| TG0070 | In distribution | |
| TG0065 | In distribution | |
| TG0075 | 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 |
|---|---|
| K251794 | 2026-09-03 |
| K213028 | 2021-10-21 |
| K200761 | 2020-11-25 |
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.