Introes Pocket Bougie
INTROES POCKET BOUGIE - Endotracheal Tuber Introducer, 14FR (4.7mm) x 60cm
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 | Bomimed Inc., Canada |
|---|---|
| FDA product code | BSR |
| Device type | Stylet, Tracheal Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5790 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-08-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OL-E12102 | 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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-08-19 | Class II | Nonconforming Material/Component | The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation. | 760 units | 2019-07-19 |
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.