Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017520736

FEI Number

3017520736

Entity Name

VENTEC LIFE SYSTEMS, INC.

City/State/Country

Woodinville, WA, US

Establishment Address

12350 NE Woodinville Drive, Building D, Suite A, Woodinville, WA 98072, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

REACT HEALTH (Owner Number: 10054872)

Owner / Operator Contact Address

22002 26th avenue SE, Bothell, WA 98021, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K020332

PMA Number

N/A

All Registered Proprietary Names

VOCSN Optiflow Optiflow

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2017-05-07
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2017-05-07
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2017-05-07
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2017-05-07
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2017-05-07
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2017-05-07
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2017-05-07
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2022-12-07
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2022-12-07

Official Correspondent

Shalini Yadav

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

REACT HEALTH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013095415	VENTEC LIFE SYSTEMS, INC.	Bothell, WA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017520736. Last updated year: 2026. Please use registration number 3017520736 when referencing this establishment in official correspondence.