AG Cuffill (Mmhg)
AG Cuffill measures and manually adjusts the pressure inside the cuffs of endotracheal tubes, tracheostomy tubes and laryngeal mask airways. It is used under medical supervision in…
AG Cuffill measures and manually adjusts the pressure inside the cuffs of endotracheal tubes, tracheostomy tubes and laryngeal mask airways. It is used under medical supervision in hospitals, emergency medical services, extended care facilities and outpatient clinics where a patient may be intubated.
The handheld device is shaped like a syringe, with a sensitive pressure gauge built into its plunger. The operator uses the syringe mechanism to regulate cuff pressure while reading the battery powered gauge. This version displays pressure in millimeters of mercury.
Use Limit
AG Cuffill is intended for one patient and is limited to 100 operations. It can be cleaned with disinfectant during that use period, and is discarded when its permitted use is complete.
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 6) |
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 10, carton of 200 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HSCUFF0031 | 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.