CoughAssist
CoughAssist, Adult Facemask, Large, with hose, filter, and adapter
1manufacturer
44catalogue numbers in this listing
1510(k) clearance
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 | Respironics Inc., United States |
|---|---|
| FDA product code | NHJ |
| Device type | Device, Positive Pressure Breathing, Intermittent |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K121955 |
| Record published | 2016-09-23 |
| Record revised | 2021-06-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 15 to 95 % RH; Storage environment temperature -4 to 140 °F |
| Distribution end date | 2022-10-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00 | In distribution | |
| CoughAssist 70 Series Circuit, Adult Large, 6ft | In distribution | |
| CoughAssist, Facemask, Adult Small | In distribution | |
| CoughAssist E70 Series Oximetry Interface Kit | In distribution | |
| CoughAssist, Adapter, 22mm x 15mm | In distribution | |
| 00 | In distribution | |
| CoughAssist 70 Series Circuit, Mouthpiece, 6ft | In distribution | |
| CoughAssist 70 Series, Water Trap | In distribution | |
| CoughAssist 70 Series Circuit, Toddler, 9ft | In distribution | |
| CoughAssist 70 Series Circuit, Trach, 6ft | In distribution | |
| CoughAssist 70 Series Circuit, Adult Small, 9ft | In distribution | |
| CoughAssist, Facemask, Toddler | In distribution | |
| CoughAssist 70 Series Circuit, Adult Medium, 9ft | In distribution | |
| CoughAssist 70 Series Circuit, Adult Large, 9ft | In distribution | |
| CoughAssist 70 SERIES, FOOT PEDAL | In distribution | |
| 00 | In distribution | |
| CoughAssist, E70, INTL | In distribution | |
| CoughAssist 70 Series Circuit, Toddler, 6ft | In distribution | |
| CoughAssist, FaceMask, Adult Large | In distribution | |
| CoughAssist 70 Series Circuit, Adult Small, 6 ft | In distribution | |
| CoughAssist 70 Series Circuit, Infant, 9ft. | In distribution | |
| CoughAssist E70 INTL, IT | In distribution | |
| CoughAssist, Adapter, 22mm x 22mm | In distribution | |
| CoughAssist T70, US | In distribution | |
| CoughAssist 70 Series Circuit, Infant, 6ft | In distribution | |
| CoughAssist 70 Series, 6ft clear tube | In distribution | |
| Smooth Bore Tube, 22mm X 36″ | In distribution | |
| CoughAssist, Mouthpiece | In distribution | |
| 00 | In distribution | |
| 00 | In distribution | |
| 00 | In distribution | |
| CoughAssist, Facemask, Adult Medium | In distribution | |
| Facemask, Adult, Large, with Hose, Filter, Adapter | In distribution | |
| CoughAssist 70 Series Circuit, Mouthpiece, 9ft | In distribution | |
| CoughAssist 70 Series Circuit, Trach, 9ft | In distribution | |
| CoughAssist, Facemask, Infant | In distribution | |
| 00 | In distribution | |
| CoughAssist 70 Series Circuit, Adult Medium, 6ft | In distribution | |
| CoughAssist 70 Series, Mouthpiece | In distribution | |
| E70 | In distribution | |
| CoughAssist Circuit Breathing F/EM2 | Withdrawn | |
| CoughAssist, E70, BR | Withdrawn | |
| CoughAssist, E70, JP | Withdrawn | |
| CoughAssist, E70, CN | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Percussionaire | Percussionaire Corp. | 40 |
| The MetaNeb®System | Hill-Rom Services Pte, Ltd. | 14 |
| The VitalCough®System | Hill-Rom Services Pte, Ltd. | 10 |
| 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 |
|---|---|
| K121955 | 2012-12-14 |
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.