Stylet – Tracheal Tube/ Bougie Catheter
2 catalogue numbers from CM001, listed by Gmmi SDN BHD, Malaysia, under Stylet, Tracheal Tube. 34 manufacturers in China are registered for this product code.
34manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (10), Jiangsu (9), Guangdong (8). 11 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 Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Hangzhou Formed Medical Devices Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| Tianjin Medis Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
Showing 12 of 34. All 34 manufacturers in China registered for Stylet, Tracheal Tube
Record
| Listed by | Gmmi SDN BHD, Malaysia |
|---|---|
| FDA product code | BSR |
| Device type | Stylet, Tracheal Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5790 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-06-08 |
| Record revised | 2020-12-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, carton of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CM001 | In distribution | |
| CM002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SunMed | SunMed Group Holdings, LLC | 22 |
| Stylet, Tracheal Tube | VBM Medizintechnik Gmbh | 17 |
| Hudson RCI | Teleflex Medical LLC | 16 |
| SourceMark | Sourcemark, LLC. | 13 |
| Intubating Stylet | Well Lead Medical Co., Ltd. | 11 |
| AincA® | Anesthesia Associates, Inc. | 8 |
| Medline | Medline Industries, Inc. | 8 |
| Sheridan | Teleflex Medical LLC | 7 |
| Rusch | Teleflex Medical LLC | 6 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
| Anesthesia | Sunset Healthcare Solutions, Inc. | 4 |
| Vital Signs™ | Airlife, Inc. | 4 |
Showing 12 of 86. All products under Stylet, Tracheal Tube
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.