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VENTEC LIFE SYSTEMS, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
22002 26th Ave SE, Bothell, WA, 98021
Website
—
LinkedIn
—
Facebook
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Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
—
FDA FEI Number
3013095415
DUNS Number
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Catalogue (76)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
VOCSN Patient Breathing Package Pediatric, Active, Blue
FDA UDI
Class IIActive
VOCSN Fan Filters 25-Pack
FDA UDI
Class IIActive
VOCSN Patient Breathing Package Pediatric, Active, Oxygen, Blue
FDA UDI
Class IIActive
VOCSN External Bacterial Filter PRT-00790-001
FDA UDI
Class IIActive
HomeFill® Oxygen System HF2POSTD
FDA UDI
Class IIActive
Vocsn V*Home, English
FDA UDI
Class IIActive
VOCSN Patient Breathing Package Pediatric, Active, Heated, Blue
FDA UDI
Class IIActive
VOCSN Patient Breathing Package Pediatric, Valveless, Heated, Blue
FDA UDI
Class IIActive
VOCSN Patient Air Intake Filters 25-Pack
FDA UDI
Class IIActive
VOCSN Patient Breathing Package Adult, Passive, Oxygen, Blue
FDA UDI
Class IIActive
Vocsn V+C+Pro, English
FDA UDI
Class IIActive
VOCSN Power Supply PRT-00990-000
FDA UDI
Class IIActive
Vocsn V+C+S+N+Pro, English
FDA UDI
Class IIActive
Internal Battery PM Upgrade USB Drive PRT-01846-000
FDA UDI
Class IIActive
VOCSN Patient Breathing Package Adult, Active, Oxygen, Blue
FDA UDI
Class IIActive
VOCSN Patient Breathing Package Pediatric, Valveless, Blue
FDA UDI
Class IIActive
VOCSN Power Supply PRT-01333-000
FDA UDI
Class IIActive
VOCSN Humidifier Bypass Blue
FDA UDI
Class IIActive
VOCSN Roll Stand PRT-00569-000
FDA UDI
Class IIActive
VOCSN Nurse Call Cable Normally Closed
FDA UDI
Class IIActive
VOCSN Nurse Call Cable Normally Open
FDA UDI
Class IIActive
Platinum® 10L Oxygen Concentrator IRC10LXO2
FDA UDI
Class IIActive
VOCSN Removable Battery Quick Charger PRT-01003-000
FDA UDI
Class IIActive
VOCSN High Flow Kit 5-Week High Flow Nasal Cannula Kit
FDA UDI
Class IIActive
VOCSN Patient Breathing Package Adult, Active, Heated, Oxygen, Blue
FDA UDI
Class IIActive
VOCSN Unified Respiratory System K162877
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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Authorities

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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.

DateRecall No.ClassStatusReason
Mar 25, 2026Z-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, 2025Z-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, 2024Z-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, 2021Z-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.