VYAIRE MEDICAL, INC.

Matched from indexed company URL: Vyaire Medical

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3013421741	3013421741	VYAIRE MEDICAL, INC.	1	Y	2026-01-01	26125 North Riverwoods Blvd Mettawa IL US 60045
2021710	2021710	Vyaire Medical, Inc.	1	Y	2020-04-25	1100 BIRD CENTER DRIVE Palm Springs CA US 92262
9615102	1000271197	Vyaire Medical GmbH.	1	N	2020-04-25	LEIBNIZSTRASSE 7 HOECHBERG Bayern DE 97204
3010838917	3010838917	Vyaire Medical Oy	1	N	2020-04-25	Kuortaneenkatu 2 Helsinki Etela-Suomen laani FI FIN-00510
3014101041	3014101041	Vyaire Medical Pty Ltd	1	N	2020-04-25	Level 5, 7 Eden Park Drive Level 5, 7 Eden Park Drive Sydney New South Wales AU 2113
3015973929	3015973929	Vyaire Medical, Inc.	1	N	2020-04-25	510 Technology Dr. Irvine CA US 92618

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
20190752101729	Multi-Link™ - X2 Single-Patient-Use Long ECG Leadwire Set 6-Lead Set, Grabber, AHA, 3.6m/ 12ft	+1-833-327-3284	customersupport@vyaire.com

vyaire.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
200656	1280134639	P890057	MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR	LSZ	1991-03-29
201104	1280134639	P890057	MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR	LSZ	1991-03-29
239488	1280134639	P890057	MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR	LSZ	1991-03-29
200656	1540370244	K993833	AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS	BZE	1999-12-10
201104	1218806085	K993449	BIRD V.I.P. GOLD/STERLING	CBK	1999-12-20
201104	1311807522	K992788	BEAR CUB 750 PSV	CBK	1999-09-16
200928	1972587042	K992323	DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES	MLD	1999-11-01
200656	1261569922	K992214	OXYCON PRO	BZC	2000-02-22
200674	1261569922	K992214	OXYCON PRO	BZC	2000-02-22
239488	1261569922	K992214	OXYCON PRO	BZC	2000-02-22
201104	1005090712	K991972	INFANT FLOW SYSTEM	BZD	1999-08-13
200656	1470009511	K991484
201104	1461458412	K990856	HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682	BZD	2000-01-11
201104	1133956963	K984254	INFANT FLOW NCPAP MASKS	BZD	1999-02-24
201104	1810762098	K984056	LTV 1000	CBK	1999-04-12
201104	1106853546	K983981	BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE	CBK	1998-11-20
201104	1180681510	K982580	BIRD MONITOR INTERFACE	CBK	1998-10-22
201104	1329945763	K981971	TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3	CBK	1998-08-24
201104	1354985624	K981371	LTV 1000 VENTILATOR	CBK	1998-10-30
200656	1399207537	K981366	STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES	BTY	1998-10-30
201104	1399207537	K981366	STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES	BTY	1998-10-30
239488	1399207537	K981366	STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES	BTY	1998-10-30
200928	1812610446	K980582	MULTI-LINK CABLE AND LEAD WIRE SYSTEMS	DSA	1998-03-16
212486	1812610446	K980582	MULTI-LINK CABLE AND LEAD WIRE SYSTEMS	DSA	1998-03-16
201104	1378424844	K974303	INFANT FLOW SYSTEM	BZD	1998-01-30
201104	1862510213	K973646	BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER	BZR	1998-05-07
200674	1894330904	K972419	TOENNIES NEUROSCREEN SYSTEM	IKN	1998-04-30
201104	1364375168	K972203	BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT	CBK	1997-11-06
200656	1682570960	K970811	DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN	JOH	1998-11-13
239488	1682570960	K970811	DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN	JOH	1998-11-13
200674	1480595052	K965042	MICRODL DIARYCARD SPIROMETER	BZG	1997-06-17
201104	1153814951	K963131	GRASEBY ANDERSEN'S, INTEGRITY S700	BZG	1997-02-14
200674	1766623769	K963035	MICRO SPIROMETER	BZG	1996-11-01
200656	1940537972	K962220	HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER	BZE	1997-01-14
200656	1961573685	K961838	RESPIRGARD II, SPIROGARD	CAH	1996-10-18
201104	1469810377	K955865	BEAR CUB INFANT PRESSURE VENTILATOR	CBK	1996-08-06
200656	1611181927	K951047	BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA	CAH	1995-06-02
201104	1063734023	K950484	TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR	CBK	1996-05-03
200674	1096211880	K950197	MICROCO	CCJ	1996-10-17
239488	1096211880	K950197	MICROCO	CCJ	1996-10-17
201104	1656157734	K942852	RESPITRACE PT	DQK	1996-02-13
201104	1513613396	K942211	VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS	BTY	1994-11-22
200674	1986652416	K940375	MICRO MPM	CAP	1994-11-21
200674	1217302663	K936108	MASTERSCREEN BODY	JEH	1995-02-03
239488	1217302663	K936108	MASTERSCREEN BODY	JEH	1995-02-03
200674	1828747658	K933839	MASTER SCREEN PNUEMO	BTY	1994-03-07
239488	1585907974	K932799	SINGLE USE MANUAL RESUSCITATOR PEEP VALVE	BYE	1993-09-03
200656	1563658167	K932557	HYPERINFLATION SYSTEM	BZR	1993-07-22
201104	2001460023	K931422	DELTATRAC(TM) II METABOLIC MONITOR	BZL	1993-11-24
200656	1611911367	K930747	BIRD 8400TI ADULT VOLUME VENTILATOR	CBK	1994-02-15
201104	1611911367	K930747	BIRD 8400TI ADULT VOLUME VENTILATOR	CBK	1994-02-15
239488	1611911367	K930747	BIRD 8400TI ADULT VOLUME VENTILATOR	CBK	1994-02-15
239488	1970903897	K930252	BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)	CAI	1993-02-09
200656	1040883244	K925422	BIRD 1000 PV PORTABLE VENTILATOR	CBC	1993-05-13
201104	1040883244	K925422	BIRD 1000 PV PORTABLE VENTILATOR	CBC	1993-05-13
239488	1040883244	K925422	BIRD 1000 PV PORTABLE VENTILATOR	CBC	1993-05-13
200656	1154603447	K924671	BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT	BTM	1993-04-21
200656	1868820876	K924610	BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT	BTM	1993-04-06
200656	1206708344	K924123	SIDESTREAM DISPOSABLE	CAF	1992-11-16
201104	1624046688	K923989	SENSORMEDICS MODEL 6200 AUTOBOX DL	BZG	1993-08-09
201104	1755298240	K923988	SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS	BZG	1993-10-21
200656	1111330188	K921387	BIRD 8400ST ADULT VOLUME VENTILATOR	CBK	1993-03-11
201104	1111330188	K921387	BIRD 8400ST ADULT VOLUME VENTILATOR	CBK	1993-03-11
239488	1111330188	K921387	BIRD 8400ST ADULT VOLUME VENTILATOR	CBK	1993-03-11
200656	1746587964	K920885	VENTILATOR CIRCUITS	CAH	1992-10-23
201104	2016360867	K920246	SENSORMEDICS MODEL 922 SPIROMETER	BZG	1992-04-08
201104	1915096718	K920113	BIRD GRAPHICS MONITOR	CBK	1993-02-19
201104	1997133481	K915488	PEDIATRIC VENTILATOR AND PARTNER VOLUME MONITOR	CBK	1992-10-22
200656	1581792195	K915277	ENDOTRACHEAL CPAP SET	BTR	1992-03-20
239488	1581792195	K915277	ENDOTRACHEAL CPAP SET	BTR	1992-03-20
200656	1120673917	K915226	ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT	BZE	1993-01-12
201104	2024547768	K914485	VENTILATOR STAND	CBK	1991-10-25
200656	1864551361	K914370	MECONIUM SUCTION DEVICE (MSD)	BTR	1993-01-06
239488	1864551361	K914370	MECONIUM SUCTION DEVICE (MSD)	BTR	1993-01-06
200656	1751949783	K914337	GAS SAMPLING INTERFACES	CCK	1992-03-11
201104	1992495951	K913790	SENSORMEDICS OXYSHUTTLE II(TM)	DQA	1992-02-26
200656	1987021059	K912625	MOUTH TO MASK RESUSCITATOR	BTM	1991-08-02
239488	1987021059	K912625	MOUTH TO MASK RESUSCITATOR	BTM	1991-08-02
201104	2051776696	K912619	BEAR 7 VENTILATOR	CBK	1992-06-11
200656	1774613256	K912578	20CM/H20 PEEP VALVE	BYE	1991-09-11
201104	1302236748	K911962	BIRD SENTRY AIR/OXYGEN MICROBLENDER	BZR	1991-10-08
200656	1273225115	K911865	NORTEC CONNECTING TUBE SET	GAZ	1991-11-01
200656	1945005359	K911465	INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL	BZD	1991-10-18
201104	1040717196	K911336	BIRD NEBULIZATION SYNCHRONIZER	CBK	1991-11-29
200656	1983263002	K910856	MANUAL RESUSCITATOR	BTM	1991-06-18
239488	1983263002	K910856	MANUAL RESUSCITATOR	BTM	1991-06-18
200656	1635769999	K904874	ADJUSTABLE PEEP VALVE	BYE	1991-01-08
201104	2060432949	K903011	RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL	BZQ	1991-03-29
201104	2054605434	K901885	PARTNER VOLUME MONITOR	BZK	1990-09-27
200656	1676405283	K901728	ONE-LUNG CPAP DEVICE	BYE	1990-08-14
201104	1687357769	K900722	LOW FLOW N2O/02O MICROBLENDER	BZR	1990-07-18
239488	1340388619	K895913	STANDARD NEBULIZER HEATER	CAF	1989-12-22
200656	1295845823	K895866	DIRD INGANT O2 (BIO 2 HOOD)	BYL	1989-10-27
201104	1295845823	K895866	DIRD INGANT O2 (BIO 2 HOOD)	BYL	1989-10-27
239488	1295845823	K895866	DIRD INGANT O2 (BIO 2 HOOD)	BYL	1989-10-27
201104	1887297311	K895695	BIRD MICROBLENDER M.R.I.	BZR	1990-07-06
201104	1592910544	K895541	V.I.P. BIRD INFANT - PEDIATRIC VENTILATOR	CBK	1990-03-08
201104	1037452613	K894322	8400ST VOLUME VENTILATOR	CBK	1990-01-29
200656	1971502615	K883964	AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER	CAF	1988-11-30
201104	1867192090	K883038	P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER	BZR	1988-11-16
200656	2050780072	K881086	LIFEGUARD MOUTH TO MASK RESUSCITATOR	BTM	1988-04-14
201104	1104175221	K880721	6400ST INTERFACE MODULE-RS232	CBK	1988-04-14
200656	1564201874	K874395	RESPIRGARD II NEBULIZER SYSTEM	CAF	1987-12-21
200656	1002366254	K873634	BEAR VH-820 HUMIDIFIER	BTT	1987-12-02
201104	1002366254	K873634	BEAR VH-820 HUMIDIFIER	BTT	1987-12-02
239488	1002366254	K873634	BEAR VH-820 HUMIDIFIER	BTT	1987-12-02
201104	1736558502	K864547	BIRD 6500 AIR COMPRESSOR	BTI	1987-01-12
201104	1123501899	K863228	BIRD 6400ST VOLUME VENTILATOR	CBK	1987-02-10
239488	1123501899	K863228	BIRD 6400ST VOLUME VENTILATOR	CBK	1987-02-10
201104	1448422843	K862617	SENSORMEDICS OXYSHUTTLE(TM)	DQA	1986-09-26
200674	1070438854	K853434	ERGO-PNEUMOTEST	BZL	1986-02-05
200674	1420738971	K853360	N20 TEST	CBR	1985-09-03
200656	1701951008	K853146	RESPIR THER HUMID CONTAIN STERILE WATER FOR USP	BTT	1985-08-06
239488	1910348487	K851074	VARIABLE NEBULIZER HEATER	CAF	1985-06-18
200656	1635199596	K850265	AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE	CAH	1985-04-05
200674	1502042160	K843855	ERGOTEST 40 & 45	ISP	1984-11-27
200674	1502635012	K843850	UNIVERSAL-ERGOTEST	ISD	1984-11-27
200674	1128192151	K843847	O2 TEST	CCL	1984-10-12
200674	1147143892	K843845	CO TEST	CCJ	1984-10-12
200674	1259273535	K843844	CO2 TEST	CCK	1984-10-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
CBK	52	2021-11-10
CAF	25	2013-04-25
BZC	15	2019-08-23
BTT	14	2016-08-25
BZG	14	2014-12-29
BZD	14	2005-08-03
BTY	11	2012-11-19
BTM	10	1993-04-21
DSA	9	2019-09-13
CCK	9	2018-04-30
BZR	9	2010-04-02
BZE	8	2017-09-14
CAH	8	2011-10-17
FLL	6	2006-09-29
BYE	6	1993-09-03
BTR	5	2005-02-18
JEH	4	2008-04-22
CBP	4	2003-04-22
DQA	3	2015-03-20
FPA	3	2013-08-29
CCM	3	2009-05-18
CAP	3	2002-08-22
CCJ	3	1996-10-17
CBC	3	1993-05-13
LSZ	3	1991-03-29
BYL	3	1989-10-27
DQK	2	2016-09-16
LGZ	2	2013-06-14
DRX	2	2009-08-21
EYC	2	2006-08-18
NFB	2	2003-05-02
MNR	2	2003-02-12
JOH	2	1998-11-13
BZL	2	1993-11-24
EOQ	1	2009-05-22
FRO	1	2008-12-18
FMG	1	2005-09-09
FMF	1	2005-08-16
BZH	1	2003-08-27
OLV	1	2001-08-02

PMA#

Model 3100A/B High Frequency Oscillatory Ventilator

2022-07-22

Vyaire Medical Inc.26125 Riverwoods Blvdmettawa, IL 60045 PMA NumberP890057 Supplement NumberS025 Date Received04/25/2022 Decision Date07/22/2022 Product Code LSZ Advisory Committee Anesthesiology Supplement Typereal-time Process Supplement Reason Change D...