FDA.reportPublic FDA data

CAREFUSION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30124100773012410077CAREFUSION1Y2026-01-013750 Torrey View Court San Diego CA US 92130
30139436423013943642CAREFUSION1N2020-04-25120 S. State College, Suite 100 Brea CA US 92821

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2567201196545049K993147DECAPFPA1999-11-02
2567201051475561K974363BECTON DICKINSON BLUNT PLASTIC CANNULAFMI1998-06-03
2567201067479657K974083CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKSFMG1998-01-13
2567201649987017K974006BECTON DICKINSON TWINPAKFMI1998-01-22
2567201047426827K970485SMARTSITE ACCESS PINFPA1997-04-21
2567201655665039K960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSFPA1996-04-04
2567201987994648K951922ADMINISTRATION SETS WITH BALL FLOATFPA1995-07-19
2567201266633393K950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSFRN1995-06-21
2567201768975355K945070VERSASAE PLASTIC CANNULA- 11 GAUGEFPA1995-01-13
2567201559223468K944320VENTED/NON-VENTED GEMINI ADMINISTRATION SETFPA1995-02-14
2567201071289078K934095IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETSFPA1994-08-10
2567201967703396K931550EZ ADMINISTRATION SETFPA1994-01-10
2567201507575272K931173PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CHFPA1994-04-15
2567201284051220K925228IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VALFPA1993-07-30
2567201579419343K924718SHROUDED NEEDLE DEVICESFPA1993-06-18
2567201147341539K924439BECTON DICKINSON INTERLINK VIAL ACCESS CANNULAFMI1993-02-12
2567201905047390K894842IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADMFPA1989-09-12
2567201347105292K882302IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080FPA1988-07-12
2567201237377524K874564MINIMED III INFUSION PUMP & UNI-SET ADMIN SETFRN1988-02-11
2567201642178654K833033INFUSION SET-52-05-1 20 DROPS-MI VOLFPA1983-11-07
2567201645709112K820278INTRAVASCULAR ADMINISTRATION SETFPA1982-02-18
2567201835851107K81188530-30-2 700 SYRINGE EXTENSION SETFPA1981-08-25
2567201542985462K811110MODELS: 52-01-0, 52-01-1FPA1981-06-11
2567201824773312K801614MODEL 40-30-2 AIR ELIMINATING FILTER SETFPB1980-08-13
2567201363059810K790582INTRAVASCULAR ADMINISTRATION SETFPA1979-05-29
2567201306430875K790108FILTERSET 0.22, I.V. PUMPFPA1979-03-06
2567201326646335K780130BURETTE INTRAVENOUS ADMIN. SETS.FPA1978-02-21
2567201585322850K250325BD Alaris Pump Infusion SetFPA2025-10-30
2567201008141839K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceLHI2024-03-06
2567201716143045K231888BD Texium™ Needle-Free SyringeFMF2023-09-25
2567201360232832K223088BD SmartSite™ Needle-Free ConnectorFPA2023-04-07
2567201006196919K223076BD Texium™ Closed Male LuerONB2023-03-24
2567201832883244K221327BD Alaris™ Pump Infusion SetsFPA2023-07-21
2567201386222534K171957MaxZero Extension Sets with Needless ConnectorFPA2017-07-19
2567201303644053K171132Carefusion NeutraClear Needle-free connectorFPA2017-07-31
2567201966543907K171118Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)FPA2017-08-15
2567201785615545K171117Carefusion NeutraClear Needle-free connector (EL-NC1000)FPA2017-09-01
2567201870288665K143234MaxZero Administration SetsFPA2014-11-20
2567201217339860K142527Extension Set with BD Q-Syte Luer Access Split SeptumFPA2014-09-19
2567202072786806K141138SURFLASH SAFETY I.V. CATHETERFOZ2014-05-30
2567201956367378K140831MAXZERO EXTENSION SET WITH NEEDLESS CONNECTORFPA2014-04-15
2567201124975231K132863SMARTSITE VIALSHIELDLHI2013-10-04
2106111955502279K132413MZ1000FPA2013-08-29
2567201990753617K132413MZ1000FPA2013-08-29
2567201961079377K123267SURFFLASH(R) PLUS SAFETY I.V. CATHETERFOZ2012-11-02
2567201470668368K122544TERUMO SURFLASH SAFETY I.V. CATHETERFOZ2012-09-05
2567201851525835K122265VIALOK SINGLE VIAL ACCESS DEVICE VENTEDLHI2012-08-14
2567201287090279K121182VIALOK NON-VENTEDLHI2012-05-03
2567201678713144K083765MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIALFPA2008-12-30
2567201478845647K083472MEDEGEN PRESSURE RATED EXTENSION SETSFPA2008-12-09
2106111070493765K072542MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTORFPA2007-09-25
2567201955582396K072542MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTORFPA2007-09-25
2567201670221089K071400SMARTSITE STOPCOCKFMG2007-12-14
2567201430273524K071108TEXIUM SYRINGEFMF2007-05-24
2567201321776155K061285SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETSFPA2006-07-26
2567201858562398K053049ALARIS SAFETY MALE LUERFPA2006-01-12
2567201629726727K052790SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBDLHI2005-12-23
2106111270443804K052330TRU-SWAB STOCOCKFMG2005-09-09
2106111883711043K051939MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTORFPA2005-08-01
2567201990943997K051930DRUG ACCESS SPIKEFMF2005-08-16
2106112073482434K051930DRUG ACCESS SPIKEFMF2005-08-16
2106111145872634K051499INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SETFPA2005-06-22
2567201517903230K051499INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SETFPA2005-06-22
2567201168462869K050115BLOOD HAND PUMP ADMINISTRATION SETBRZ2005-04-01
2106111231821837K041179MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTORFPA2004-06-04
2567202067553641K032147SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIESFRN2003-07-25
2567201647953152K022209ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETSFPA2002-08-06
2567201536772707K013621BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100FPA2002-04-16
2567201278330785K013087SINGLE DOSE DISPENSING PIN, MODEL 2201LHI2001-11-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA462025-10-30
LHI72024-03-06
FMF42023-09-25
FOZ32014-05-30
FMG32007-12-14
FRN32003-07-25
FMI31998-06-03
BRZ22005-04-01
ONB12023-03-24
FPB11980-08-13

PMN#