Hyperinflation System
Hyperinflation System with 3L breathing bag
2manufacturers in China registered for this device type
64catalogue numbers in this listing
Who Else Makes It
Concentrated in Fujian (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
Record
| Listed by | Mercury Medical Enterprises, LLC, United States |
|---|---|
| FDA product code | NHK |
| Device type | Resuscitator, Manual, Non Self-Inflating |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K001714 |
| Record published | 2015-09-24 |
| Record revised | 2020-05-19 (version 5) |
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, expiry date, manufacturing date |
| Packaging | Pack of 20 |
| Distribution end date | 2021-05-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-55857 | In distribution | |
| 10-55855 | In distribution | |
| 10-55828 | In distribution | |
| 10-55813 | In distribution | |
| 10-55846 | In distribution | |
| 10-55831 | In distribution | |
| 10-55810 | In distribution | |
| 10-55864 | In distribution | |
| 10-55801 | In distribution | |
| 10-55822 | In distribution | |
| 10-55868 | In distribution | |
| 10-55836 | In distribution | |
| 10-55819 | In distribution | |
| 10-55856 | In distribution | |
| 10-55806 | In distribution | |
| 10-55840 | In distribution | |
| 10-55842 | In distribution | |
| 10-55803 | In distribution | |
| 10-55817 | In distribution | |
| 10-55830 | In distribution | |
| 10-55863 | In distribution | |
| 10-55802 | In distribution | |
| 10-55832 | In distribution | |
| 10-55843 | In distribution | |
| 10-55804 | In distribution | |
| 10-55827 | In distribution | |
| 10-55866 | In distribution | |
| 10-55833 | In distribution | |
| 10-55837 | In distribution | |
| 10-55844 | In distribution | |
| 10-55834 | In distribution | |
| 10-55860 | In distribution | |
| 10-55867 | In distribution | |
| 10-55862 | In distribution | |
| 10-55853 | In distribution | |
| 10-55823 | In distribution | |
| 10-55815 | In distribution | |
| 10-55848 | In distribution | |
| 10-55869 | In distribution | |
| 10-55826 | In distribution | |
| 10-55858 | In distribution | |
| 10-55835 | In distribution | |
| 10-55845 | In distribution | |
| 10-55838 | In distribution | |
| 10-55841 | In distribution | |
| 10-55854 | In distribution | |
| 10-55809 | In distribution | |
| 10-55807 | In distribution | |
| 10-55824 | In distribution | |
| 10-55839 | In distribution | |
| 10-55811 | In distribution | |
| 10-55814 | In distribution | |
| 10-55861 | In distribution | |
| 10-55820 | In distribution | |
| 10-55812 | In distribution | |
| 10-58872 | In distribution | |
| 10-55818 | In distribution | |
| 10-55808 | In distribution | |
| 10-55805 | In distribution | |
| 10-55816 | In distribution | |
| 10-55821 | In distribution | |
| 10-55829 | In distribution | |
| 10-55800 | In distribution | |
| 10-55847 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 129 |
| Portex | ICU Medical, Inc | 45 |
| NuFLO2 Hyperinflation System | Mercury Medical Enterprises, LLC | 44 |
| Venti.Plus | Galemed Corp. | 6 |
| Venti.Plus | GaleMed (Xiamen) Co., Ltd. | 4 |
| Breathing Bag | Mercury Medical Enterprises, LLC | 4 |
| Endure Industries | Endure Industries, Inc. | 2 |
| Disposable Medical Hyperinflation System | SunMed Group Holdings, LLC | 2 |
| Curaplex | Bound Tree Medical, LLC | 1 |
| Ventlab Hyperinflation System | Ventlab, LLC | 1 |
| Hyperinflation | Mercury Medical Enterprises, LLC | 1 |
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.