Servo-Air Lite
Servo-air Lite assists ventilation in spontaneously breathing patients with respiratory failure or chronic respiratory insufficiency. It supports adults and children weighing at least 15…
Servo-air Lite assists ventilation in spontaneously breathing patients with respiratory failure or chronic respiratory insufficiency. It supports adults and children weighing at least 15 kilograms through invasive or noninvasive ventilation. Healthcare professionals use it in professional healthcare facilities and during transport within those facilities.
The patient unit mixes and delivers gas, while a separate user interface sets and monitors ventilation. It provides controlled or supported breaths at constant pressure and a selected oxygen concentration. It can also deliver high flow therapy at a constant flow.
Monitoring and Power
Visual and audible alarms identify parameters outside preset limits and record alarm events. Battery modules support operation during mains failure or transport within a facility. The system is not intended for transport between facilities.
Who Else Makes It
Concentrated in Guangdong (3), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Record
| Listed by | Maquet Critical Care AB, Sweden |
|---|---|
| FDA product code | MNT |
| Device type | Sv70 Ventilator |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K230173 |
| Record published | 2023-09-21 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6893200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BiPAP A40 | Respironics Inc. | 102 |
| Philips | Respironics California, Inc. | 29 |
| DreamMapper | Respironics Inc. | 27 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 25 |
| BiPAP | Respironics Inc. | 11 |
| EncoreAnywhere | Respironics Inc. | 10 |
| Care Orchestrator | Respironics Inc. | 8 |
| A Series | Respironics Inc. | 7 |
| Nihon Kohden | Nihon Kohden Orangemed, LLC | 6 |
| Remote Alarm | Resmed PTY Ltd. | 5 |
| Stellar | Resmed PTY Ltd. | 5 |
| AF811 | Respironics Inc. | 4 |
Showing 12 of 53. All products under Sv70 Ventilator
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230173 | 2023-07-06 |
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.