VCI (Vortran Cuff Inflator)
The VORTRAN Cuff Inflator measures and manually adjusts pressure inside endotracheal, tracheostomy and laryngeal mask airway cuffs. It is a handheld disposable device for intubated…
The VORTRAN Cuff Inflator measures and manually adjusts pressure inside endotracheal, tracheostomy and laryngeal mask airway cuffs. It is a handheld disposable device for intubated patients, used under medical supervision in hospitals, emergency care, extended-care facilities or outpatient clinics.
The device provides a cuff-pressure measurement while allowing the operator to regulate inflation manually. Its measuring range is 0 to 60 cmH2O, with a stated accuracy of plus or minus 3 cmH2O within the 20 to 40 cmH2O operating range.
Listed Item
The VORTRAN® Cuff Inflator (VCI) is a hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes.
Monitoring Role
The cuff inflator is used to assess and adjust the airway tube’s cuff rather than deliver ventilation. It is intended for manual pressure regulation at the cuff.
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 | Vortran Medical Technology 1, Inc., United States |
|---|---|
| FDA product code | BSK |
| Device type | Cuff, Tracheal Tube, Inflatable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5750 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K173914 |
| Record published | 2018-08-31 |
| Record revised | 2019-03-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2450 | 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 |
|---|---|
| K173914 | 2018-05-25 |
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.