Life2000
LIFE2000 Ventilator Packaged
1manufacturer
1catalogue number
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 |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
Record
| Listed by | Hill-Rom Services Pte, Ltd., Singapore |
|---|---|
| FDA product code | NOU |
| Device type | Continuous, Ventilator, Home Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Record published | 2023-01-06 |
| Record revised | 2024-08-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BT-20-0002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vivo 50 | Breas Medical, Inc. | 17 |
| Patient Circuit | Flight Medical Innovations Ltd. | 13 |
| Astral | Resmed PTY Ltd. | 12 |
| Trilogy Evo | Respironics Inc. | 10 |
| Trilogy | Respironics Inc. | 10 |
| Care Orchestrator | Respironics Inc. | 10 |
| Trilogy 200 | Respironics Inc. | 5 |
| Continuous Ventilator | Flight Medical Innovations Ltd. | 3 |
| Trilogy 100 | Respironics Inc. | 3 |
| Vocsn Roll Stand | Ventec Life Systems, Inc. | 2 |
| Sensor | Respironics Inc. | 2 |
| Astral Double Limb Kit | Resmed PTY Ltd. | 1 |
Showing 12 of 28. All products under Continuous, Ventilator, Home Use
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2024-12-20 | Class I | Process control | There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable. | 187 units |
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.