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Sign in to claim this brandVENTEC LIFE SYSTEMS, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 22002 26th Ave SE, Bothell, WA, 98021
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3013095415
- DUNS Number
- —
Catalogue (76)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VOCSN Patient Breathing Package | Pediatric, Active, Blue | FDA UDI | Class II | Active |
| VOCSN Fan Filters | 25-Pack | FDA UDI | Class II | Active |
| VOCSN Patient Breathing Package | Pediatric, Active, Oxygen, Blue | FDA UDI | Class II | Active |
| VOCSN External Bacterial Filter | PRT-00790-001 | FDA UDI | Class II | Active |
| HomeFill® Oxygen System | HF2POSTD | FDA UDI | Class II | Active |
| Vocsn | V*Home, English | FDA UDI | Class II | Active |
| VOCSN Patient Breathing Package | Pediatric, Active, Heated, Blue | FDA UDI | Class II | Active |
| VOCSN Patient Breathing Package | Pediatric, Valveless, Heated, Blue | FDA UDI | Class II | Active |
| VOCSN Patient Air Intake Filters | 25-Pack | FDA UDI | Class II | Active |
| VOCSN Patient Breathing Package | Adult, Passive, Oxygen, Blue | FDA UDI | Class II | Active |
| Vocsn | V+C+Pro, English | FDA UDI | Class II | Active |
| VOCSN Power Supply | PRT-00990-000 | FDA UDI | Class II | Active |
| Vocsn | V+C+S+N+Pro, English | FDA UDI | Class II | Active |
| Internal Battery PM Upgrade USB Drive | PRT-01846-000 | FDA UDI | Class II | Active |
| VOCSN Patient Breathing Package | Adult, Active, Oxygen, Blue | FDA UDI | Class II | Active |
| VOCSN Patient Breathing Package | Pediatric, Valveless, Blue | FDA UDI | Class II | Active |
| VOCSN Power Supply | PRT-01333-000 | FDA UDI | Class II | Active |
| VOCSN Humidifier Bypass | Blue | FDA UDI | Class II | Active |
| VOCSN Roll Stand | PRT-00569-000 | FDA UDI | Class II | Active |
| VOCSN Nurse Call Cable | Normally Closed | FDA UDI | Class II | Active |
| VOCSN Nurse Call Cable | Normally Open | FDA UDI | Class II | Active |
| Platinum® 10L Oxygen Concentrator | IRC10LXO2 | FDA UDI | Class II | Active |
| VOCSN Removable Battery Quick Charger | PRT-01003-000 | FDA UDI | Class II | Active |
| VOCSN High Flow Kit | 5-Week High Flow Nasal Cannula Kit | FDA UDI | Class II | Active |
| VOCSN Patient Breathing Package | Adult, Active, Heated, Oxygen, Blue | FDA UDI | Class II | Active |
| VOCSN Unified Respiratory System | K162877 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 25, 2026 | Z-1942-2026 | — | open, classified | Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk |
| Feb 3, 2025 | Z-1196-2025 | — | open, classified | Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered. |
| Jan 9, 2024 | Z-1070-2024 | — | open, classified | The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breathing circuit which may cause serious injury or death. The risk of injury or death is increased for ventilator dependent patients. |
| May 10, 2021 | Z-1902-2021 | — | open, classified | Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy. |