VENTEC LIFE SYSTEMS, INC.

FDA Device Registration & Listing · Bothell, WA, US · Registration 3013095415

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013095415
FEI Number
3013095415
Entity Name
VENTEC LIFE SYSTEMS, INC.
City/State/Country
Bothell, WA, US
Establishment Address
22002 26th Ave SE, Bothell, WA 98021, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
REACT HEALTH (Owner Number: 10054872)
Owner / Operator Contact Address
22002 26th avenue SE, Bothell, WA 98021, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K914488
PMA Number
N/A

All Registered Proprietary Names

Perfecto2™ Oxygen Concentrator; Platinum® Oxygen Concentrator Optiflow VOCSN Platinum® Mobile Oxygen Concentrator PreciseRx™ Pediatric Flowmeter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2023-05-22
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2022-12-07
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
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2023-05-22
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2023-05-22

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
3017520736 VENTEC LIFE SYSTEMS, INC. Woodinville, WA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K003939 Invacare Corp. VENTURE HOME FILL II, MODEL IOH 200 2001-03-21
K942357 Healthdyne, Inc. H-500 ALLIANCE OXYGEN CONCENTRATOR 1994-05-27
K042262 Sequal Technologies, Inc. INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 2004-09-10
K003472 Sequal Technologies, Inc. INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM 2001-06-04
K051895 Datex-Ohmeda, Inc. GE DATEX-OHMEDA ENGSTROM CARESTATION 2005-09-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0038-2007 Sunrise Medical 2
DeVilbiss iFill Personal Oxygen Station model number 535D.
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.

Similar Registrations

Registration Number Establishment Name Location
3004964590 AVOX SYSTEMS Lancaster, NY, US
3008841036 Oxus America, Inc. Orion Township, MI, US
3016809216 GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD. Guangzhou City Guangdong, CN
9611451 FISHER & PAYKEL HEALTHCARE, LTD. EAST TAMAKI Auckland, NZ
2515872 DeVilbiss Healthcare LLC. SOMERSET, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013095415. Last updated year: 2026. Please use registration number 3013095415 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.