ICU MEDICAL, INC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1713468	1713468	ICU MEDICAL, INC	1	Y	2026-01-01	4455 ATHERTON DR. Salt Lake City UT US 84123

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
5094	1409365194	K974589	SMARTVALVE	FPA	1998-01-09
5094	1734500013	K970855	CLAVE CONNECTOR	FPA	1997-06-24
5094	1525850981	K964435	PRIMARY IV SET	FMG	1997-04-02
5094	1408985809	K961552	CVP POLYURETHANE CATHETER	FOZ	1997-02-10
5094	2015151449	K953573	ICU STOPCOK WITH EXTENSION TUBING	FMG	1995-10-07
5094	1474270523	K941978	HIGH PRESSURE TUBING	DQO	1994-12-13
5094	2028593536	K941254	DYE MANAGEMENT SYSTEM	DQO	1994-06-13
5094	1533139269	K932414	CONTINUOUS CARDIAC OUTPUT SYSTEM	DXG	1994-11-14
5094	1236802590	K932188	SAFESET RESERVOIR	KRA	1993-10-25
5094	1774146239	K932141	CARDIAC CATHETERIZATION KIT	DQO	1994-09-22
5094	1379465037	K923966	SYRINGE ADAPTOR	LHI	1993-06-18
5094	1536942273	K915571	CLAVE CONNECTOR	FPA	1992-09-21
5094	1864245887	K915171	LOPEZ VALVE TM II	KNT	1992-02-07
5094	1686957587	K914988	500 INFUSER	FRN	1992-04-06
5094	1705229674	K914299	CARDIAC CATHERIZATION KIT	DQO	1992-06-03
5094	1964672221	K913804	EXCELSIOR SINGLE LEAD DISPENSING SET	LHI	1992-02-11
5094	1177693005	K905116	PHARM-ASSIST	LHI	1991-04-25
5094	1758538869	K884318	THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM	KRB	1988-12-13
5094	1978968528	K874465	SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD	DYG	1988-05-25
5094	1555329319	K831506	DISP. TRANSDUCER W/MONITORING KIT TRANS	DRS	1983-08-12
5094	1287953849	K823007	OPTICATH HEPARIN COATED, FLOW-DIRECT	DYG	1982-11-01
5094	1274493630	K821057	FLOW DIRECTED THERMAL-DILUTION INFUSION	DYG	1982-05-18
5094	1293156438	K820674	OPTICATH	DQE	1982-03-25
5094	1986688329	K801048	ACCUDYNAMIC	DRS	1980-05-14
5094	1936848789	K791796	ADDITIVE HINGE CAP	KPE	1979-10-01
5094	1590992548	K190918	SwabTip Male Disinfectant Cap	QBP	2020-03-06
5094	1268059228	K180111	ClearGuard HD Antimicrobial Barrier Cap	PEH	2018-05-25
5094	1782419562	K170110	Diana Medication Transfer Set	ONB	2018-08-10
5094	1438248499	K152006	Cogent Hemodynamic Monitoring System	DXQ	2016-05-05
5094	1352291868	K140129	PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER	DQE	2014-07-02
5094	1207025241	K131549	CHEMOLOCK, CHEMOLOCK PORT	ONB	2013-07-26
5094	1988651984	K130975	SWABCAP AND SWABFLUSH	QBP	2013-12-24
5094	1412803827	K100576	HIGH PRESSURE SETS-400 PSI	FPA	2010-12-17
5094	1312548217	K100434	CLAVE NEUTRON	FPA	2010-07-09
5094	1618120189	K091268	HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS	DQE	2009-09-18
5094	1269324719	K090610	HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM	DRG	2009-03-13
5094	1813838099	K090189	ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE	FPA	2009-04-10
5094	1119562312	K083508	SWABCAP	QBP	2009-04-28
5094	1658099832	K082806	SPINNING SPIROS, MODEL CH-2000	FPA	2009-04-06
5094	1006541029	K081361	CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX	FPA	2008-08-28
5094	1739335170	K080077	CLAVE STOPCOCK	FMG	2008-02-13
5094	1778577633	K080007	GRADUATED ADAPTER WITH CLAVE	EZD	2008-05-13
5094	1455059846	K070979	PULL TAB SQUEEZE FLUSH	KRA	2007-09-19
5094	1291346854	K070532	SPIROS	FPA	2007-03-20
5094	1426542923	K061585	OPTICATH CENTRAL VENOUS OXIMETRY CATHETER	DQE	2006-10-05
5094	1818503421	K061573	TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT	DRS	2006-09-19
5094	1950152160	K061450	HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS	DQE	2006-08-04
5094	1649150194	K052828	DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)	DRS	2006-02-17
5094	1025017632	K042182	Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432	FPA	2004-09-01
5094	1019330494	K021874	ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711	DXG	2002-07-12
5094	1265102947
5094	1330605345
5094	1334661321
5094	1579482393
5094	2005433345
5094	2047178725

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FPA	10	2010-12-17
DQE	5	2014-07-02
DRS	4	2006-09-19
DQO	4	1994-12-13
QBP	3	2020-03-06
FMG	3	2008-02-13
LHI	3	1993-06-18
DYG	3	1988-05-25
ONB	2	2018-08-10
KRA	2	2007-09-19
DXG	2	2002-07-12
PEH	1	2018-05-25
DXQ	1	2016-05-05
DRG	1	2009-03-13
EZD	1	2008-05-13
FOZ	1	1997-02-10
FRN	1	1992-04-06
KNT	1	1992-02-07
KRB	1	1988-12-13
KPE	1	1979-10-01

PMN#

ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
2009-04-10
ICU MEDICAL, INC
SPINNING SPIROS, MODEL CH-2000
2009-04-06
ICU MEDICAL, INC
GRADUATED ADAPTER WITH CLAVE
2008-05-13
ICU MEDICAL, INC
UNIVERSAL VIAL ACCESS SPIKE
2008-05-02
ICU MEDICAL, INC
CLAVE STOPCOCK
2008-02-13
ICU MEDICAL, INC
ICU MEDICAL SINGLE-USE SYRINGE
2007-10-05
ICU MEDICAL, INC
PULL TAB SQUEEZE FLUSH
2007-09-19
ICU MEDICAL, INC
GENIE, MODEL CH-200
2007-06-05
ICU MEDICAL, INC
DYE MANAGEMENT SYSTEM
2007-04-16
ICU MEDICAL, INC
SPIROS
2007-03-20
ICU MEDICAL, INC