FDA.reportPublic FDA data

CareFusion 303, INC.

Matched from indexed company URL: CAREFUSION 303,INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20164932016493CareFusion 303, INC.1Y2026-01-0110020 Pacific Mesa Blvd SAN DIEGO CA US 92121
30038792463003879246CareFusion 303, INC1Y2026-01-013750 Torrey View Ct San Diego CA US 92130

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 GUDIDProductPhoneEmail
10885403512582BD Pyxis - BD Pyxis MedStation ES (Mini Main)+1(800)727-6102productcomplaints@bd.com
10885403512599BD Pyxis - BD Pyxis MedStation ES (Mini Auxiliary)+1(800)727-6102productcomplaints@bd.com
10885403512674BD Pyxis - BD Pyxis MedStation ES Tower+1(800)727-6102productcomplaints@bd.com
10885403512698BD Pyxis - BD Pyxis MedStation ES Tower (Auxiliary)+1(800)727-6102productcomplaints@bd.com
10885403512704BD Pyxis - BD Pyxis Medflex 1000 BD Pyxis Medflex 2000+1(800)727-6102productcomplaints@bd.com
10885403513794BD Pyxis - BD Pyxis MedBank (Cabinet Software v2.X)+1(800)727-6102productcomplaints@bd.com
10885403513817BD Pyxis - BD Pyxis MedBank Tower (MedPass Software v1.X)+1(800)727-6102productcomplaints@bd.com
10885403513824BD Pyxis - BD Pyxis CUBIE System (Software v1.X)+1(800)727-6102productcomplaints@bd.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
235941092288150K970485SMARTSITE ACCESS PINFPA1997-04-21
235941739053816K961486IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KITMRZ1998-04-17
235941647582215K960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSFPA1996-04-04
235941114059871K955846MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETERFLL1996-10-01
235941397548076K951922ADMINISTRATION SETS WITH BALL FLOATFPA1995-07-19
235941003324603K950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSFRN1995-06-21
235941071228807K946168IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPSLZH1996-03-21
235941652833363K945070VERSASAE PLASTIC CANNULA- 11 GAUGEFPA1995-01-13
235941892603575K944320VENTED/NON-VENTED GEMINI ADMINISTRATION SETFPA1995-02-14
235941749596338K934095IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETSFPA1994-08-10
235941350045058K933144GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLERFRN1993-10-12
235941528261892K931550EZ ADMINISTRATION SETFPA1994-01-10
235941378297028K931549MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMPFRN1993-10-12
235941369418130K931173PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CHFPA1994-04-15
235942056072802K925228IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VALFPA1993-07-30
235941761026460K924718SHROUDED NEEDLE DEVICESFPA1993-06-18
235941474448461K921378IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLEFRN1992-06-09
235941389472266K896914IVAC MODEL 2090 INFRA RED THERMOMETERFLL1990-03-02
235942018193800K894842IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADMFPA1989-09-12
235941839692604K882302IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080FPA1988-07-12
235942012120687K880479IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMPFRN1988-04-25
235941309191929K874564MINIMED III INFUSION PUMP & UNI-SET ADMIN SETFRN1988-02-11
235941005196125K872952ULTRASONIC AIR-IN-LINE DETECTOR (AILD)FRN1987-10-20
235941236526977K862295MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLERFRN1986-09-23
235941648056292K860436IVAC MODEL 2080 ELECTRONIC THERMOMETERFLL1986-02-12
235941374467086K833033INFUSION SET-52-05-1 20 DROPS-MI VOLFPA1983-11-07
235941791113903K823018MODEL 460 INTERMITTENT MEDICATION DELIVFLN1983-01-26
235941848744530K820764IVAC MODEL 160 AIR-IN-LINE SENSORFRN1982-04-15
235941964298161K820569IVAC #1160 MULTIPLE VITAL SIGNS UNITDXN1982-03-18
235941609211742K820409ELECTRONIC CLINICAL THERMOMETER TEMP PRFLL1982-03-02
235941414341185K820278INTRAVASCULAR ADMINISTRATION SETFPA1982-02-18
235941862025051K81188530-30-2 700 SYRINGE EXTENSION SETFPA1981-08-25
235941215448220K811110MODELS: 52-01-0, 52-01-1FPA1981-06-11
235941824950004K801614MODEL 40-30-2 AIR ELIMINATING FILTER SETFPB1980-08-13
235941704208880K790582INTRAVASCULAR ADMINISTRATION SETFPA1979-05-29
235941955623855K790108FILTERSET 0.22, I.V. PUMPFPA1979-03-06
235941685371998K780130BURETTE INTRAVENOUS ADMIN. SETS.FPA1978-02-21
235941227000082K243855BD Alaris Infusion System with Guardrails Suite MXFRN2025-04-25
835411227000082K243855BD Alaris Infusion System with Guardrails Suite MXFRN2025-04-25
835411494061004K211218BD Alaris System with Guardrails Suite MX v12.1.2FRN2023-07-21
235941494061004K211218BD Alaris System with Guardrails Suite MX v12.1.2FRN2023-07-21
235941685987156K171957MaxZero Extension Sets with Needless ConnectorFPA2017-07-19
235941725647632K171132Carefusion NeutraClear Needle-free connectorFPA2017-07-31
235941518545845K171118Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)FPA2017-08-15
235941810600124K171117Carefusion NeutraClear Needle-free connector (EL-NC1000)FPA2017-09-01
235941232869730K143234MaxZero Administration SetsFPA2014-11-20
235941488591341K141138SURFLASH SAFETY I.V. CATHETERFOZ2014-05-30
235941451319065K140831MAXZERO EXTENSION SET WITH NEEDLESS CONNECTORFPA2014-04-15
235941983112485K133532ALARIS SYSTEM WITH GUARDRAILS SUITE MXFRN2014-08-21
235941092695328K132863SMARTSITE VIALSHIELDLHI2013-10-04
235941607294194K132413MZ1000FPA2013-08-29
235941717297818K123267SURFFLASH(R) PLUS SAFETY I.V. CATHETERFOZ2012-11-02
235941380584844K122544TERUMO SURFLASH SAFETY I.V. CATHETERFOZ2012-09-05
235941657564049K122265VIALOK SINGLE VIAL ACCESS DEVICE VENTEDLHI2012-08-14
235941778987790K121182VIALOK NON-VENTEDLHI2012-05-03
235941470923284K083765MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIALFPA2008-12-30
235941238804634K083472MEDEGEN PRESSURE RATED EXTENSION SETSFPA2008-12-09
235941668970532K072542MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTORFPA2007-09-25
235941919014565K072105ALARIS SYSTEM WITH MMS, MODEL 8XXXFRN2007-12-28
235941700959836K071400SMARTSITE STOPCOCKFMG2007-12-14
235941214649714K071108TEXIUM SYRINGEFMF2007-05-24
235941566261139K061285SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETSFPA2006-07-26
235941147841673K053049ALARIS SAFETY MALE LUERFPA2006-01-12
235942016156980K052790SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBDLHI2005-12-23
235941043607676K051930DRUG ACCESS SPIKEFMF2005-08-16
835411161859193K051641ALARIS SYSTEM PC UNIT, MODEL 8001FRN2005-10-20
235941161859193K051641ALARIS SYSTEM PC UNIT, MODEL 8001FRN2005-10-20
235942047596941K051499INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SETFPA2005-06-22
235941559421006K050230TURBO TEMP TRIOFLL2005-02-16
235941915892221K050115BLOOD HAND PUMP ADMINISTRATION SETBRZ2005-04-01
235941309147784K043299MEDLEY PCA MODULE, MODEL 8120MEA2004-12-10
835411309147784K043299MEDLEY PCA MODULE, MODEL 8120MEA2004-12-10
235941310685436K041241MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600FRN2004-07-06
235941066274406K032233MEDLEY PCA MODULE, MODEL 8120MEA2003-09-09
235941562958446K032147SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIESFRN2003-07-25
835411397839901K031741MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300CCK2004-02-09
235941397839901K031741MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300CCK2004-02-09
235941656786197K030459MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)FRN2003-04-04
235941680870455K023264MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110FRN2002-12-19
235941607271617K022677MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLEDQA2002-09-11
235941631026764K022209ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETSFPA2002-08-06
235942053352837K013087SINGLE DOSE DISPENSING PIN, MODEL 2201LHI2001-11-13
235941735219168K012383GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT CFRN2001-10-02
835411151532062K010966MEDLEY SP02 MODULE, MODEL 8220DQA2001-06-08
235941151532062K010966MEDLEY SP02 MODULE, MODEL 8220DQA2001-06-08
835411356831502
235941356831502

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA332017-09-01
FRN222025-04-25
LHI52013-10-04
FLL52005-02-16
FOZ32014-05-30
MEA32004-12-10
DQA32002-09-11
FMF22007-05-24
CCK22004-02-09
FMG12007-12-14
BRZ12005-04-01
MRZ11998-04-17
LZH11996-03-21
FLN11983-01-26
DXN11982-03-18
FPB11980-08-13

PMN#

GUDID#

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