Medis
Endotracheal Tube,With Subglottic Suction Port and HVLP Cuff 7.0
9manufacturers in China registered for this device type
15catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Tianjin Medis Medical Device 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, Specification developer, Manufacturer |
| 510(k) | K160694 |
| Record published | 2020-05-11 |
| Record revised | 2020-06-19 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 30 °C |
| Packaging | Inner box of 10, carton of 10 |
| Sizes | Catheter inner diameter 6 to 9 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ETT-P22-90 | Catheter Inner Diameter 9.0 mm | In distribution |
| ETT-X22-70 | Catheter Inner Diameter 7.0 mm | In distribution |
| ETT-X22-60 | Catheter Inner Diameter 6.0 mm | In distribution |
| ETT-P22-65 | Catheter Inner Diameter 6.5 mm | In distribution |
| ETT-X22-80 | Catheter Inner Diameter 8.0 mm | In distribution |
| ETT-P22-70 | Catheter Inner Diameter 7.0 mm | In distribution |
| ETT-J22-90 | Catheter Inner Diameter 9.0 mm | In distribution |
| ETT-X22-75 | Catheter Inner Diameter 7.5 mm | In distribution |
| ETT-P22-80 | Catheter Inner Diameter 8.0 mm | In distribution |
| ETT-J22-80 | Catheter Inner Diameter 8.0 mm | In distribution |
| ETT-J22-70 | Catheter Inner Diameter 7.0 mm | In distribution |
| ETT-P22-75 | Catheter Inner Diameter 7.5 mm | In distribution |
| ETT-P22-60 | Catheter Inner Diameter 6.0 mm | In distribution |
| ETT-X22-90 | Catheter Inner Diameter 9.0 mm | In distribution |
| ETT-J22-60 | Catheter Inner Diameter 6.0 mm | 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 |
|---|---|
| K190274 | 2019-07-30 |
| K160694 | 2017-04-07 |
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.