VOCSN Unified Respiratory System
VENTEC LIFE SYSTEMS, INC
VENTEC LIFE SYSTEMS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013095415 | 3013095415 | VENTEC LIFE SYSTEMS, INC. | 1 | Y | 2026-01-01 | 22002 26th Ave SE Bothell WA US 98021 |
| 3017520736 | 3017520736 | VENTEC LIFE SYSTEMS, INC. | 1 | N | 2026-01-01 | 12350 NE Woodinville Drive Building D, Suite A Woodinville WA US 98072 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 222557 | 1543082829 | K914488 | MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS | CAW | 1992-09-15 |
| 222557 | 1586920343 | K200890 | Invacare Perfecto2V Oxygen Concentrator | CAW | 2020-08-06 |
| 222557 | 1361706931 | K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity | CAW | 2019-08-29 |
| 222557 | 1926876136 | K162877 | VOCSN Unified Respiratory System | CBK | 2017-04-07 |
| 281407 | 1926876136 | K162877 | VOCSN Unified Respiratory System | CBK | 2017-04-07 |
| 222557 | 1610450026 | K160630 | Invacare Platinum Mobile Oxygen Concentrator | CAW | 2016-09-27 |
| 222557 | 1606801108 | K021685 | VENTURE HOMEFILL II WITH OXYGEN CONSERVER | CAW | 2002-07-23 |
| 222557 | 1685024090 | K020386 | INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 | CAW | 2002-07-02 |
| 222557 | 1467492446 | K020332 | RESPIRATORY HUMIDIFIER, MODEL MR850 | BTT | 2003-07-07 |
| 281407 | 1467492446 | K020332 | RESPIRATORY HUMIDIFIER, MODEL MR850 | BTT | 2003-07-07 |
| 222557 | 1808166384 | ||||
| 281407 | 1808166384 |
Product Codes Associated With Registrations#
PMN#
GUDID#
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Adult, Active, Oxygen, Blue)
2020-10-07
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Adult, Active, Heated, Oxygen, Blue)
2020-10-07
VOCSN - V+C, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com
2021-02-23
VOCSN External Bacterial Filter - PRT-00790-001
2017-11-11
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Adult, Active, Oxygen, Blue)
2017-11-11
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Adult, Passive, Oxygen, Blue)
2017-11-11
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Adult, Passive, Blue)
2019-01-30
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Adult, Active, Heated, Blue)
2019-01-30
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Adult, Passive, Heated, Blue)
2019-01-30
VOCSN Nurse Call Cable - VOCSN Nurse Call Cable, Normally Closed
2017-11-11
VOCSN Nurse Call Cable - VOCSN Nurse Call Cable, Normally Open
2017-11-11
VOCSN Travel Suction Canister - PRT-00824-000
2017-11-11
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Pediatric, Valveless, Blue)
2019-01-30
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Adult, Valveless, Blue)
2019-01-30
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Adult, Valveless, Heated, Blue)
2019-01-30
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Pediatric, Valveless, Heated, Blue)
2019-01-30
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Pediatric, Active, Blue)
2018-07-10
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Pediatric, Active, Heated, Blue)
2018-07-11
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue)
2018-07-11
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Pediatric, Active, Heated, Oxygen, Blue)
2018-07-11
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Pediatric, Passive, Blue)
2018-07-11
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Pediatric, Passive, Heated, Blue)
2018-07-11
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Pediatric, Passive, Oxygen, Blue)
2018-07-11
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Pediatric, Passive, Heated, Oxygen, Blue)
2018-07-11
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Adult, Active, Blue)
2020-07-22
VOCSN Patient Breathing Package - VOCSN Patient Breathing Package (Adult, Active, Heated, Blue)
2020-07-22
VOCSN Patient Air Intake Filters - VOCSN Patient Air Intake Filters, 3-Pack
2020-07-22
VOCSN Fan Filters - VOCSN Fan Filters, 3-Pack
2020-07-22
VOCSN High Flow Kit - The Ventec High Flow Nasal Cannula Kit contains the following items:- 5x Adult, Valveless Heated Ventec One-Circuit (00855573007235)- 5x Humidifier Bypass (00855573007136)- 5x Optiflow+ Adult Cannula, Medium (09420012429117)- 5x Auto-fill Disposable Adult Humidification Chamber (09420012432025)- 1x High Pressure O2 Hose (14896138006587)- 1x Temperature Probe (09420012401311)- 1x 850 Heater Wire Adapter (09420012421548)- 1x Water Bag Pole (09420012405920)- 1x MR850 Heated Humidifier (09420012407290)
2020-10-05
VOCSN High Flow Kit - Pediatric High Flow Nasal Cannula Kit
2022-12-08
Internal Battery PM Upgrade USB Drive - Eaches- Internal Battery PM Upgrade USB Drive, PRT-01907-000 - 00850018761451
2025-12-02
Internal Battery PM Upgrade USB Drive - Eaches- Internal Battery PM Upgrade USB Drive, PRT-01846-000 - 00850018761413Packaged, Internal Battery PM Upgrade USB Drive (5-Pack), PRT-01848-000 - 00850018761420
2025-08-06
Platinum® 10L Oxygen Concentrator - IRC10LXO2
2024-12-20
VOCSN Passive Valve - Passive Valve
2024-12-02
HomeFill® Oxygen System - IOH200
2023-10-16
HomeFill® Oxygen System - HF2PC9
2023-10-16
HomeFill® Oxygen System - HF2POST9
2023-10-16
HomeFill® Oxygen System - HF2POSTD
2023-10-16
VOCSN - V*Home, English
2023-06-30
PreciseRx™ Pediatric Flowmeter - IRCPF16
2023-06-16