SourceMark
Tube, Endo, Oral and Nasal, Murphy, Cuffed 8.0 + Stylet, Aluminum
9manufacturers in China registered for this device type
148catalogue 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 | Sourcemark, LLC. |
|---|---|
| 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 | 2020-07-08 |
| Record revised | 2020-07-09 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, box of 10, box of 5, 10 of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0655U | In distribution | |
| M0445C | In distribution | |
| MX0480C | In distribution | |
| M0440U | In distribution | |
| M0425U | In distribution | |
| M0730U | In distribution | |
| MX0475C | In distribution | |
| M0770C | In distribution | |
| M0490C | In distribution | |
| M0540U | In distribution | |
| M0640C | In distribution | |
| M0750U | In distribution | |
| M0545U | In distribution | |
| M0655C | In distribution | |
| M0645U | In distribution | |
| M0430C | In distribution | |
| M0740U | In distribution | |
| M0675C | In distribution | |
| M0775C | In distribution | |
| M0470C | In distribution | |
| M0630U | In distribution | |
| M0460U | In distribution | |
| M0665C | In distribution | |
| M0585C | In distribution | |
| M0475C | In distribution | |
| M0455C | In distribution | |
| M0555U | In distribution | |
| M0665C | In distribution | |
| M0530C | In distribution | |
| M0480C | In distribution | |
| M0440C | In distribution | |
| M0560C | In distribution | |
| M0650U | In distribution | |
| M0555U | In distribution | |
| M0440U | In distribution | |
| M0630U | In distribution | |
| M0550U | In distribution | |
| M0675C | In distribution | |
| M0670C | In distribution | |
| M0485C | In distribution | |
| M0585C | In distribution | |
| M0650C | In distribution | |
| M0460C | In distribution | |
| M0430U | In distribution | |
| M0570C | In distribution | |
| M0645C | In distribution | |
| M0450C | In distribution | |
| MX0480C | In distribution | |
| M0650U | In distribution | |
| M0555C | In distribution | |
| M0420U | In distribution | |
| M0550C | In distribution | |
| M0535C | In distribution | |
| M0450U | In distribution | |
| M0435C | In distribution | |
| M0440C | In distribution | |
| M0635U | In distribution | |
| M0540C | In distribution | |
| MX0465C | In distribution | |
| M0765C | In distribution | |
| M0425U | In distribution | |
| M0455U | In distribution | |
| M0765C | In distribution | |
| M0555C | In distribution | |
| M0420U | In distribution | |
| M0560U | In distribution | |
| M0540C | In distribution | |
| M0470C | In distribution | |
| M0450C | In distribution | |
| M0485C | In distribution | |
| M0745U | In distribution | |
| M0780C | In distribution | |
| M0460U | In distribution | |
| M0750U | In distribution | |
| M0640U | In distribution | |
| M0760C | In distribution | |
| M0475C | In distribution | |
| M0530U | In distribution | |
| M0760C | In distribution | |
| M0660U | In distribution | |
| M0640C | In distribution | |
| M0785C | In distribution | |
| M0455C | In distribution | |
| M0445C | In distribution | |
| M0680C | In distribution | |
| M0660C | In distribution | |
| M0565C | In distribution | |
| M0735U | In distribution | |
| M0665U | In distribution | |
| M0740U | In distribution | |
| M0550U | In distribution | |
| M0465C | In distribution | |
| M0780C | In distribution | |
| M0465C | In distribution | |
| M0655C | In distribution | |
| M0550C | In distribution | |
| M0580C | In distribution | |
| M0580C | In distribution | |
| M0445U | In distribution | |
| M0460C | In distribution | |
| M0455U | In distribution | |
| M0435U | In distribution | |
| M0450U | In distribution | |
| M0730U | In distribution | |
| M0655U | In distribution | |
| M0635U | In distribution | |
| M0535U | In distribution | |
| MX0475C | In distribution | |
| M0655U | In distribution | |
| M0530C | In distribution | |
| M0575C | In distribution | |
| M0535C | In distribution | |
| M0480C | In distribution | |
| M0560C | In distribution | |
| M0745U | In distribution | |
| M0575C | In distribution | |
| MX0465C | In distribution | |
| M0670U | In distribution | |
| M0535U | In distribution | |
| M0560U | In distribution | |
| M0775C | In distribution | |
| M0645U | In distribution | |
| M0755C | In distribution | |
| M0670U | In distribution | |
| M0435C | In distribution | |
| M0660U | In distribution | |
| M0565C | In distribution | |
| M0445U | In distribution | |
| M0540U | In distribution | |
| M0680C | In distribution | |
| M0660C | In distribution | |
| M0785C | In distribution | |
| M0570C | In distribution | |
| M0755C | In distribution | |
| M0545C | In distribution | |
| M0670C | In distribution | |
| M0770C | In distribution | |
| M0640U | In distribution | |
| M0645C | In distribution | |
| M0490C | In distribution | |
| M0545C | In distribution | |
| M0530U | In distribution | |
| M0735U | In distribution | |
| M0430C | In distribution | |
| MX470C | In distribution | |
| MX0470C | In distribution | |
| M0650C | In distribution | |
| M0545U | 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 |
| Montgomery® Safe-T-Tube™ | Boston Medical Products, Inc. | 144 |
| Sunmed | SunMed Group Holdings, LLC | 112 |
| Forsure | Forsure Medical Products LLC. | 101 |
| Sheridan | Teleflex Medical LLC | 100 |
Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 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 |
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.