The VitalCough®System
Respiratory Care
1manufacturer
10catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Hill-Rom Services Pte, Ltd., Singapore |
|---|---|
| FDA product code | NHJ |
| Device type | Device, Positive Pressure Breathing, Intermittent |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Record published | 2016-09-17 |
| Record revised | 2026-04-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2026-04-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M06828 | In distribution | |
| 180411 | In distribution | |
| M06831 | In distribution | |
| M06825 | In distribution | |
| M06827 | In distribution | |
| M06826 | In distribution | |
| M06829 | In distribution | |
| M06830 | In distribution | |
| M06563 | Withdrawn | |
| PVC1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoughAssist | Respironics Inc. | 44 |
| Percussionaire | Percussionaire Corp. | 40 |
| The MetaNeb®System | Hill-Rom Services Pte, Ltd. | 14 |
| Synclara Cough System | Hill-Rom Services Pte, Ltd. | 10 |
| Volara System | Hill-Rom Services Pte, Ltd. | 9 |
| Vocsn Patient Breathing Package | Ventec Life Systems, Inc. | 7 |
| Clearo | Breas Medical, Inc. | 6 |
| Maximus System | Hill-Rom Services Pte, Ltd. | 6 |
| BiWaze Clear Dual Lumen Circuit With Face Mask – Adult Small | Abmrc LLC | 3 |
| BiWaze Cough Dual Lumen Circuit With Face Mask – Adult Large | Abmrc LLC | 3 |
| The Vest APX System | Hill-Rom Services Pte, Ltd. | 2 |
| Vortran PercussiveNEB 2.0 w/ Top Nebulizer Port | Vortran Medical Technology 1, Inc. | 1 |
Showing 12 of 32. All products under Device, Positive Pressure Breathing, Intermittent
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200988 | 2020-05-26 |
| K192143 | 2020-02-14 |
| K151689 | 2016-03-17 |
| K124032 | 2013-04-25 |
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.