Portex
Catalogue number 292003, listed by ICU Medical, Inc, United States, under Cuff, Tracheal Tube, Inflatable. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1), Tianjin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Quasar Electronics Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| TDG Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 1 |
| Tianjin Medis Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Medtronic (Shanghai) Medical Technology Co., Ltd. | Min Hang District | Shanghai | Specification developer | 4 |
| Shanghai Longmann Tech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | BSK |
| Device type | Cuff, Tracheal Tube, Inflatable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5750 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K833327 |
| Record published | 2015-08-07 |
| Record revised | 2025-04-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 292003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CuffGuard | Idmed Corp. | 12 |
| Cuff, Tracheal Tube, Inflatable | VBM Medizintechnik Gmbh | 6 |
| Rusch | Teleflex Medical LLC | 5 |
| Cuff, Tracheal Tube, Inflatable | Nuvasive, Inc. | 4 |
| Tracoe® technic | Tracoe Medical Gmbh | 4 |
| Medis | Tianjin Medis Medical Device Co., Ltd. | 3 |
| AincA® | Anesthesia Associates, Inc. | 2 |
| Puritan Bennett | Covidien LP | 2 |
| CuffTrek | Shanghai Longmann Tech Co., Ltd. | 2 |
| Posey | Posey Products, LLC | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Cuffix | Biovo Technologies, Ltd. | 2 |
Showing 12 of 29. All products under Cuff, Tracheal Tube, Inflatable
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.