Venti.Plus
1.0 Hyperinflation W/ Manmtr, Mask
2manufacturers in China registered for this device type
4catalogue 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 | GaleMed (Xiamen) Co., Ltd., China |
|---|---|
| FDA product code | NHK |
| Device type | Resuscitator, Manual, Non Self-Inflating |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K092687 |
| Record published | 2015-09-19 |
| Record revised | 2022-10-24 (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 |
| Storage | Storage environment temperature -30 to 50 °C |
| Packaging | Carton of 20, carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5407 | In distribution | |
| 5408 | In distribution | |
| 5405 | In distribution | |
| 5406 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 129 |
| Hyperinflation System | Mercury Medical Enterprises, LLC | 64 |
| Portex | ICU Medical, Inc | 45 |
| NuFLO2 Hyperinflation System | Mercury Medical Enterprises, LLC | 44 |
| Venti.Plus | Galemed Corp. | 6 |
| 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.