AG Cuffill (cmH2O)
Catalogue number HSCUFF0041, listed by Hospitech Respiration, Israel, 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
4510(k) clearances naming this product code
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 | Hospitech Respiration, Israel |
|---|---|
| FDA product code | BSK |
| Device type | Cuff, Tracheal Tube, Inflatable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5750 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K122721 |
| Record published | 2016-09-16 |
| Record revised | 2019-03-21 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -32 to 104 °F; Handling environment temperature -32 to 104 °F |
| Packaging | Carton of 200, carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HSCUFF0041 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221477 | 2022-12-29 |
| K180991 | 2018-10-12 |
| K150157 | 2016-02-16 |
| K122721 | 2013-05-03 |
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.