Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013421741

FEI Number

3013421741

Entity Name

VYAIRE MEDICAL, INC.

City/State/Country

Mettawa, IL, US

Establishment Address

26125 North Riverwoods Blvd, Mettawa, IL 60045, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Vyaire Medical (Owner Number: 10053153)

Owner / Operator Contact Address

26125 North Riverwoods Blvd, Mettawa, IL 60045, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101643

PMA Number

N/A

All Registered Proprietary Names

LTV1150 LTV2 LTV 2200 Heliox Low Flow Sentry Blender Infant Flow LTV 1000 Breathing Circuits LTV2 Accessory/Component LTV 1200 Ventilator 3100 High Frequency Oscillating Ventilator LTV 1200 MR LTV Series Ventilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2016-12-08
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2023-08-30
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2016-12-07
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2020-08-26
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2016-12-08
MOQ	Battery, Replacement, Rechargeable	General, Plastic Surgery	Class 1	878.4820	2023-08-31
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2016-12-08
LSZ	Ventilator, High Frequency	Unknown	Class 3	N/A	2016-12-07
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2016-12-08
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2016-11-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vyaire Medical

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

View Entity Profile →

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

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

Similar Registrations

Registration Number	Establishment Name	Location
3029922922	ORIGIN MEDICAL DEVICES HUNGARY KFT	Vac Pest, HU
3012667060	HMC Premedical S.p.A.	Medolla Modena, IT
2024500	COVIDIEN	CARLSBAD, CA, US
3001104093	DRAEGERWERK AG & CO. KGAA	LUEBECK Schleswig-Holstein, DE
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013421741. Last updated year: 2026. Please use registration number 3013421741 when referencing this establishment in official correspondence.