Disposable Medical Hyperinflation System
AirLife™ Hyperinflation System, Transport Elbow, 8' Oxygen Tubing with Threaded Nut
2manufacturers in China registered for this device type
2catalogue 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 | SunMed Group Holdings, 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, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2025-11-10 |
| Record revised | 2026-01-29 (version 3) |
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, manufacturing date |
| Packaging | Pack of 50, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7-N7910 | In distribution | |
| 0413 | 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 |
| Venti.Plus | GaleMed (Xiamen) Co., Ltd. | 4 |
| Breathing Bag | Mercury Medical Enterprises, LLC | 4 |
| Endure Industries | Endure Industries, Inc. | 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.