WESTMED, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2028807	1000374126	WESTMED, INC.	1	N	2026-01-01	5580 S NOGALES HWY TUCSON AZ US 85706

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
46270	2045466716	K973238	ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER	CAH	1998-03-11
46270	1686551124	K963910	HEART NEBULIZER #100609	CAF	1996-12-16
46270	1911593394	K955047	WESTMED CIRCULARIE PEP DEVICES	BYE	1996-03-27
46270	1059087308	K954271	WESTMED CONDESATE COLLECTION TRAP	CAW	1995-12-28
46270	1442244043	K951484	WESTMED BACTERIAL/VIRAL FILTER	CAH	1995-04-24
46270	1262620169	K944941	PISTON SYRINGE	CBT	1994-12-05
46270	2003109212	K943600	UNIHEART	CAF	1994-10-13
46270	1255930675	K940581	BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS	BTM	1994-05-06
46270	1669886022	K934310	BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR	BTM	1993-12-14
46270	1101112500	K932709	PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM	BZR	1993-07-23
46270	2051636008	K931924	MARKSMAN ARTERIAL BLOOD GAS SYRINGE	JKA	1993-08-03
46270	1966926330	K926055	THE MILLER NEBULIZER SYSTEM	CAF	1993-02-03
46270	1484065496	K925173	BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT	LYA	1993-01-15
46270	1764772620	K924667	AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY)	CAF	1993-08-26
46270	1332241550	K923618	PEEP VALVE	BYE	1992-08-03
46270	1714871738	K923596	HEART NEBULIZER	CAF	1992-10-15
46270	1238672782	K922492	SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER	CAH	1992-08-24
46270	1333149028	K920443	MININEB	CAF	1992-07-02
46270	1313374607	K914778	NEOLINE(TM)	CBT	1992-09-16
46270	1647749127	K913163	NON REBREATHING VALVE	CBP	1992-02-03
46270	1414623222	K904538	MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT	CAI	1991-04-24
46270	1702960350	K881451	SIMPLEX UNIVERSAL HEATED TUBING SLEEVE	BZE	1988-06-10
46270	1718382401	K870173	LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL	BTT	1987-04-03
46270	1883305025	K822786	MDM ARTERIAL BLOOD GAS KIT	CBT	1982-10-21
46270	1330462419	K800562	DISPOSABLE HAND HELD NEBULIZER	CAF	1980-03-25
46270	1850373865	K162343	Westmed Gas Sampling Cannula with O2 delivery	CCK	2016-12-14
46270	1080017238	K133057	VIBRALUNG ACOUSTICAL PERCUSSOR	SDT	2014-05-23
46270	1475093026	K130091	PULMOSAL	CAF	2013-03-13
46270	1697903705	K121382	WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]	CAH	2012-12-06
46270	1405325554	K110713	WATERPAP VALVE	BYE	2011-09-12
46270	1750636158	K091862	NESSI SPACER	NVO	2009-11-20
46270	1754119819	K072220	PEDI CO2 EASY	CCK	2007-08-23
46270	1471657802	K070128	CO2 EASY	CCK	2007-02-15
46270	1835581130	K040991	AMBU DISPOSABLE PRESSURE MANOMETER	CAP	2004-07-22
46270	1014673473	K040712	AIR SAFETY HEPA, MODEL 3500	MOD	2004-06-03
46270	1511327569	K031413	VIGORMIST COMPRESSOR NEBULIZER	BTI	2003-10-07
46270	1579848212
46270	1086147277
46270	1127609424
46270	1159402931
46270	1197270607
46270	1218474765
46270	1254118912
46270	1322810328
46270	1412942071
46270	1418332375
46270	1450150712
46270	1454059949
46270	1509800199
46270	1541957473
46270	1582805008
46270	1608032266
46270	1628787059
46270	1683301120
46270	1709019391
46270	1747234914
46270	1837503160
46270	1895029007
46270	1900787513
46270	1951905858
46270	1995041552
46270	1996714742
46270	2003227695
46270	2013097512
46270	2054466916
46270	2060861920

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
CAF	8	2013-03-13
CAH	4	2012-12-06
CBT	4	1994-12-05
CCK	3	2016-12-14
BYE	3	2011-09-12
BTM	2	1994-05-06
SDT	1	2014-05-23
NVO	1	2009-11-20
CAP	1	2004-07-22
MOD	1	2004-06-03
BTI	1	2003-10-07
CAW	1	1995-12-28
JKA	1	1993-08-03
BZR	1	1993-07-23
LYA	1	1993-01-15
CBP	1	1992-02-03
CAI	1	1991-04-24
BZE	1	1988-06-10
BTT	1	1987-04-03

PMN#

Westmed Gas Sampling Cannula With O2 Delivery
2016-12-14
WESTMED, INC.
Disposable Pressure Manometer (DPM)
2015-08-11
Westmed, Inc.
VIBRALUNG ACOUSTICAL PERCUSSOR
2014-05-23
Westmed, Inc.
WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
2012-12-06
Westmed, Inc.
ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
2008-07-15
Westmed, Inc.
PEDI CO2 EASY
2007-08-23
Westmed, Inc.
CO2 EASY
2007-02-15
Westmed, Inc.
WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
1995-09-18
Westmed, Inc.

GUDID#

Adaptors/Conectors - 9" Humidifier Adaptor
WESTMED, INC.
2021-01-29
Hyperinflation (AMBU) - Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Pressure Lines
WESTMED, INC.
2015-10-24
Composite Kit - Composite Kit, High Flow Humidifier, Adult Cannula, 14' Tubing
WESTMED, INC.
2017-04-26
Humidifier Adaptor - Concentrator Humidifier Adaptor
WESTMED, INC.
2017-05-26
Composite Kit - Composite Kit,High Flow Humidifier,Adult Cannula w/25'Tubin
WESTMED, INC.
2017-05-26
OxyGo Bubble Humidifier - Bubble Humidifier, Dry
WESTMED, INC.
2018-09-25
Bubble Humidifier - Bubble Humidifier, Dry
WESTMED, INC.
2021-02-24
Bubble Humidifier - DRY BUBBLE HUMIDIFIER HIGH FLOW 6 - 20 LPM
WESTMED, INC.
2022-03-31
Bubble Humidifier - DRY BUBBLE HUMIDIFIER LOW FLOW Up To 6 LPM
WESTMED, INC.
2022-03-31
Bubble Humidifier - Concentrator Bubble Humidifier Elbow Adaptor
WESTMED, INC.
2022-03-31
Composite Kit - Composite Kit, High Flow Humidifier, Adult Cannula, 7' Tubing
WESTMED, INC.
2017-04-26
Bubble Humidifier - Bubble Humidifier, Dry, High Flow
WESTMED, INC.
2017-04-26
Mod Kit Pulset™ - Mod Kit, Pulset 3cc Syringe 22g x 1" (.7 x 25mm) Safety 25u Balanced Heparin
WESTMED, INC.
2017-03-30
Pulset - Mod Kit, Pulset 3cc Syringe 23g x 1" (.6 x 25mm) Safety Tip 25u Balanced Heparin
WESTMED, INC.
2017-03-30
A-Line - A-Line 1cc Syringe Blunt Tip Cannula, 25u BH
WESTMED, INC.
2021-01-31
Pulset - Full Kit, Pulset 3cc Syringe 23g x 1" (.6 x 25mm) safety Tip 25u Balanced Heparin
WESTMED, INC.
2017-08-31
Pulset™ 1cc Syringe - Pulset™ 1cc Syringe, Minikit, No Needle, ~15u Balanced Heparin
WESTMED, INC.
2021-04-28
Pulset™ - Modified Kit, Pulset™ 1cc syringe 25g x 5/8" Safety Tip™ ~25u balanced heparin
WESTMED, INC.
2017-09-22
Pulset - Pulset™ 3cc Syringe 23g x 1" Q-Cork 50u Balanced Heparin
WESTMED, INC.
2022-05-31
Pulset - Full Kit, Pulset 1cc Syringe 25g x 5/8" (.5 x 15.9mm) Q-Cork, 25u Balanced Heparin
WESTMED, INC.
2020-08-31
A-Line - A-Line 3cc Syringe 50u Balanced Heparin
WESTMED, INC.
2020-09-30
A-Line - A-Line 1cc Syringe, 3cc Waste syringe 25u BH
WESTMED, INC.
2020-09-30
A-Line - A-Line 3cc Syringe 23g x 1" (.6 x 25mm) Q-Cork 25u BH
WESTMED, INC.
2020-09-30
Pulset - Pulset 3cc Syringe
WESTMED, INC.
2020-09-30
Pulset - Pulset 3cc Syringe (No Heparin) Pulset 1cc Syringe 15u balanced Heparin
WESTMED, INC.
2020-09-30
Atellica® VTR Syringes - 1mL Vented Luer Slip Syringe, ~25IU Balanced Heparin, Vented Tip Cap (Private Label)
WESTMED, INC.
2022-02-28
Atellica® VTR Syringes - 1mL A-Line Aspirating Luer Slip Syringe, ~25IU Balanced Heparin, Vented Tip Cap (Private Label)
WESTMED, INC.
2022-02-28
Atellica® VTR Syringes - 1mL Vented Luer Slip Syringe, 25g x 5/8" Needle, ~25IU Balanced Heparin, Vented Tip Cap, Q-Cork (Private Label)
WESTMED, INC.
2022-02-28
Atellica® VTR Syringes - 1mL Vented Luer Slip Syringe, 25g x 5/8" Safety Tip, ~25IU Balanced Heparin, Vented Tip Cap (Private Label)
WESTMED, INC.
2022-02-28
Atellica® VTR Syringes - 3mL Vented Luer Slip Syringe, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Private Label)
WESTMED, INC.
2022-02-28
Atellica® VTR Syringes - 3mL Vented Luer Lock Syringe, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Private Label)
WESTMED, INC.
2022-02-28
Atellica® VTR Syringes - 3mL A-Line Aspirating Luer Slip Syringe, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Private Label)
WESTMED, INC.
2022-02-28
Atellica® VTR Syringes - 3mL A-Line Aspirating Luer Lock Syringe, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Private Label)
WESTMED, INC.
2022-02-28
Atellica® VTR Syringes - 3mL Vented Luer Slip Syringe 22g x 1" Needle, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap, Q-Cork (Private Label)
WESTMED, INC.
2022-02-28
Atellica® VTR Syringes - 3mL Vented Luer Slip Syringe, 22g x 1" Safety Tip, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Private Label)
WESTMED, INC.
2022-02-28
Atellica® VTR Syringes - 3mL Vented, Luer Lock Syringe, 22g x 1" Safety Tip, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Private Label)
WESTMED, INC.
2022-02-28
Atellica® VTR Syringes - 3mL Vented, Luer Lock Syringe, 23g x 1" Safety Tip, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap
WESTMED, INC.
2022-02-28
Atellica® VTR Syringes - 3mL Vented, Luer Slip Syringe, 23g x 1" Safety Tip, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Private Label)
WESTMED, INC.
2022-02-28
Pulset - Pulset 1cc Syringe 23g x 1" (.6 x 25mm) Q-Cork, 25u Balanced Heparin (Chinese Labels)
WESTMED, INC.
2022-03-31
Pulset - Pulset 1cc Syringe 25g x 5/8" (.5 x 15.9mm Q-Cork) 25u Balanced Heparin (Chinese Labels)
WESTMED, INC.
2022-03-31

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