Pylant Monitor
Pylant Monitor gives a visual indication of pressure within an endotracheal or tracheotomy tube cuff. One end connects to the tube’s external pilot-balloon port, allowing continuous or…
Pylant Monitor gives a visual indication of pressure within an endotracheal or tracheotomy tube cuff. One end connects to the tube’s external pilot-balloon port, allowing continuous or intermittent monitoring while the monitor remains attached.
A silicone diaphragm expands or contracts with pressure changes and moves an indicator across a calibrated, color-coded scale. The scale marks a range from 20 to 30 cm H2O, with a central mark at approximately 25 cm H2O.
Listed Item
Pylant Monitor – Disposable endotracheal tube cuff pressure monitor (15 units per box) – non AC-powered.
Air Connection
The opposite end accepts a medical syringe for adding or removing cuff air. Its airtight valve opens when a syringe is connected and closes when the syringe is removed, retaining air within the cuff-and-monitor connection. The diaphragm and moving indicator sit inside a protective case.
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 | KAL-MED, LLC., United States |
|---|---|
| FDA product code | BSK |
| Device type | Cuff, Tracheal Tube, Inflatable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5750 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K191858 |
| Record published | 2023-09-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Clean & dry temperature controlled location out of sunlight |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IM-1000 | 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 |
|---|---|
| K191858 | 2020-02-24 |
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.