Carefusion 303 Inc

FDA Filings

This page includes the latest FDA filings for Carefusion 303 Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2016493
• FEI Number: 2016493
• Name: CareFusion 303, INC.
• Owner & Operator: CAREFUSION 303, INC.
• Contact Address: 10020 Pacific Mesa Blvd. --; San Diego CA 92130 US
• Official Correspondent:
  • MICHELLE J BADAL
  • x-858-6175925-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 10020 PACIFIC MESA BLVD. ; SAN DIEGO, CA 92121 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 10885403519215 CAREFUSION 303, INC.	BD Alaris	2024-04-09
GUDID 10885403517945 CAREFUSION 303, INC.	Alaris	2023-11-28
GUDID 10885403517938 CAREFUSION 303, INC.	BD Alaris	2023-11-28
GUDID 10885403517921 CAREFUSION 303, INC.	BD Alaris	2023-11-28
GUDID 10885403517730 CAREFUSION 303, INC.	Alaris	2023-11-07
GUDID 10885403517723 CAREFUSION 303, INC.	BD Alaris	2023-11-07
GUDID 10885403517198 CAREFUSION 303, INC.	BD Pyxis	2023-10-09
GUDID 10885403517181 CAREFUSION 303, INC.	BD Pyxis	2023-10-09
GUDID 10885403517174 CAREFUSION 303, INC.	BD Pyxis	2023-10-09
GUDID 10885403517167 CAREFUSION 303, INC.	BD Pyxis	2023-10-09
GUDID 10885403516054 CAREFUSION 303, INC.	BD Alaris	2023-09-26
GUDID 10885403516030 CAREFUSION 303, INC.	Alaris	2023-09-26
GUDID 10885403516023 CAREFUSION 303, INC.	BD Alaris	2023-09-26
GUDID 10885403515316 CAREFUSION 303, INC.	Alaris	2023-06-28
GUDID 10885403515323 CAREFUSION 303, INC.	Alaris	2023-06-16
GUDID 10885403515231 CAREFUSION 303, INC.	BD Alaris	2023-06-16
GUDID 10885403513824 CAREFUSION 303, INC.	BD Pyxis	2022-12-12
GUDID 10885403513787 CAREFUSION 303, INC.	BD Pyxis	2022-12-12
GUDID 10885403513770 CAREFUSION 303, INC.	BD Pyxis	2022-12-12
GUDID 10885403513763 CAREFUSION 303, INC.	BD Pyxis	2022-12-12
GUDID 10885403513756 CAREFUSION 303, INC.	BD Pyxis	2022-12-12
GUDID 10885403513749 CAREFUSION 303, INC.	BD Pyxis	2022-12-12
GUDID 10885403513732 CAREFUSION 303, INC.	BD Pyxis	2022-12-12
GUDID 10885403513725 CAREFUSION 303, INC.	BD Pyxis	2022-12-12
GUDID 10885403512537 CAREFUSION 303, INC.	BD Pyxis	2022-12-12
GUDID 10885403512520 CAREFUSION 303, INC.	BD Pyxis	2022-12-12
GUDID 10885403510434 CAREFUSION 303, INC.	BD Pyxis	2022-12-12
GUDID 10885403510427 CAREFUSION 303, INC.	BD Pyxis	2022-12-12
GUDID 10885403513817 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403513800 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403513794 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403512698 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403512681 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403512674 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403512667 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403512650 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403512643 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403512636 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403512612 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403512605 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403512599 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403512582 CAREFUSION 303, INC.	BD Pyxis	2022-12-07
GUDID 10885403512704 CAREFUSION 303, INC.	BD Pyxis	2022-12-06
GUDID 10885403512575 CAREFUSION 303, INC.	BD Pyxis	2022-12-06
GUDID 10885403512568 CAREFUSION 303, INC.	BD Pyxis	2022-12-06
GUDID 10885403512551 CAREFUSION 303, INC.	BD Pyxis	2022-12-06
GUDID 10885403512544 CAREFUSION 303, INC.	BD Pyxis	2022-12-06
GUDID 10885403512629 CAREFUSION 303, INC.	Pyxis	2022-11-30
GUDID 10885403222054 CAREFUSION 303, INC.	Alaris	2022-08-24
GUDID 10885403510472 CAREFUSION 303, INC.	Alaris	2022-08-22
GUDID 10885403928659 CAREFUSION 303, INC.	Alaris	2022-07-04
GUDID 10885403510489 CAREFUSION 303, INC.	Alaris	2022-06-17
GUDID 10885403421532 CAREFUSION 303, INC.	Pyxis	2022-04-20
GUDID 10885403830013 CAREFUSION 303, INC.	Alaris	2022-02-28
GUDID 10885403812002 CAREFUSION 303, INC.	Alaris	2022-02-28
GUDID 10885403811012 CAREFUSION 303, INC.	Alaris	2022-02-28
GUDID 10885403810015 CAREFUSION 303, INC.	Alaris	2022-02-28
GUDID 10885403801518 CAREFUSION 303, INC.	Alaris	2022-02-28
GUDID 10885403230554 CAREFUSION 303, INC.	MaxZero MZ5302	2022-01-24
GUDID 10885403235375 CAREFUSION 303, INC.	Alaris, SmartSite 42493E	2022-01-20
GUDID 10885403235368 CAREFUSION 303, INC.	Alaris, SmartSite 42434E	2022-01-20
GUDID 10885403234026 CAREFUSION 303, INC.	Alaris, SmartSite 10015488	2022-01-20
GUDID 10885403227998 CAREFUSION 303, INC.	Alaris, SmartSite 2426-0007	2022-01-20
GUDID 07613203012393 CAREFUSION 303, INC.	Alaris, SmartSite 20028E	2022-01-20
GUDID 07613203011938 CAREFUSION 303, INC.	Alaris, SmartSite 2000E	2022-01-20
GUDID 07613203011778 CAREFUSION 303, INC.	Alaris, SmartSite 2205E	2022-01-20
GUDID 07613203010078 CAREFUSION 303, INC.	Alaris 72213N	2022-01-20
GUDID 10885403234408 CAREFUSION 303, INC.	Alaris 10800175	2022-01-17
GUDID 10885403234194 CAREFUSION 303, INC.	Alaris 10373772	2022-01-17
GUDID 10885403233579 CAREFUSION 303, INC.	Alaris, SmartSite 10010983	2022-01-17
GUDID 07613203020879 CAREFUSION 303, INC.	Alaris, SmartSite 10010903	2022-01-17
GUDID 10885403236334 CAREFUSION 303, INC.	MaxGuard MFS102	2022-01-12
GUDID 10885403236020 CAREFUSION 303, INC.	MaxGuard ME1055	2022-01-12
GUDID 10885403235788 CAREFUSION 303, INC.	MaxGuard M4058	2022-01-12
GUDID 10885403235757 CAREFUSION 303, INC.	MaxGuard M4020	2022-01-12
GUDID 10885403811036 CAREFUSION 303, INC.	Alaris	2021-11-15
GUDID 10885403810039 CAREFUSION 303, INC.	Alaris	2021-11-15
GUDID 10885403801532 CAREFUSION 303, INC.	Alaris	2021-11-15
GUDID 10885403812026 CAREFUSION 303, INC.	Alaris	2021-11-09
GUDID 10885403960123 CAREFUSION 303, INC.	Alaris	2021-10-18
GUDID 10885403897535 CAREFUSION 303, INC.	Alaris	2021-10-18
GUDID 10885403896125 CAREFUSION 303, INC.	Alaris	2021-10-18
GUDID 10885403830020 CAREFUSION 303, INC.	Alaris	2021-10-18
GUDID 10885403812033 CAREFUSION 303, INC.	Alaris	2021-10-18
GUDID 10885403811043 CAREFUSION 303, INC.	Alaris	2021-10-18
GUDID 10885403810046 CAREFUSION 303, INC.	Alaris	2021-10-18
GUDID 10885403801549 CAREFUSION 303, INC.	Alaris	2021-10-18
GUDID 10885403494291 CAREFUSION 303, INC.	Alaris 8120	2021-10-07
GUDID 10885403424267 CAREFUSION 303, INC.	Alaris 8110	2021-10-05
GUDID 50885403302068 CAREFUSION 303, INC.	Alaris, SmartSite MPC-02	2020-04-27
GUDID 50885403250857 CAREFUSION 303, INC.	Alaris, SmartSite MV0450	2020-04-27
GUDID 50885403238565 CAREFUSION 303, INC.	VersaSafe 9391-0300	2020-04-27
GUDID 50885403235021 CAREFUSION 303, INC.	Alaris, SmartSite 2300E-0500	2020-04-27
GUDID 50885403234888 CAREFUSION 303, INC.	Alaris, SmartSite 20053E	2020-04-27
GUDID 50885403234871 CAREFUSION 303, INC.	Alaris, SmartSite 20043E	2020-04-27
GUDID 50885403234161 CAREFUSION 303, INC.	SmartSite 10237425	2020-04-27
GUDID 37613203012028 CAREFUSION 303, INC.	Alaris, SmartSite 20019E	2020-04-27
GUDID 37613203011960 CAREFUSION 303, INC.	Alaris, SmartSite 20039E	2020-04-27
GUDID 37613203011946 CAREFUSION 303, INC.	Alaris, SmartSite 2000E	2020-04-27
GUDID 37613203011823 CAREFUSION 303, INC.	Alaris, SmartSite 2202E	2020-04-27
PMN K171118 | FPA CareFusion 303, INC.	Carefusion Neutraclear multi-fuse Extension set with needle-free connector(s)	2017-09-05
PMN K171117 | FPA CareFusion 303, INC.	Carefusion NeutraClear Needle-free Connector	2017-09-05
PMN K171132 | FPA CareFusion 303, INC.	Carefusion NeutraClear Needle-free connector	2017-08-11
PMN K171957 | FPA CareFusion 303, INC.	MaxZero Extension Sets with Needle free Connector	2017-07-27
PMN K171957 Carefusion 303 Inc.	MaxZero Extension Sets With Needless Connector	2017-07-19
PMN K163316 CAREFUSION 303, INC.	Multi-Link X2 ECG Adapter And Direct Connect Lead Wire System	2017-06-22
PMN K132863 | LHI CareFusion 303, INC.	SmartSite VialShield	2016-07-13
PMN K133532 | FRN CareFusion 303, INC.	Alaris System with Guardrails Suite MX	2016-04-26
PMN K143234 | FPA CareFusion 303, INC.	MaxZero	2014-11-21
PMN K141138 | FOZ CareFusion 303, INC.	SURFLASH SAFETY I.V. CATHETER	2014-08-28
PMN K133532 CAREFUSION 303, INC.	ALARIS SYSTEM WITH GUARDRAILS SUITE MX	2014-08-21
PMN K122265 | LHI CareFusion 303, INC.	Vented Single Vial Access Device	2014-07-21
PMN K121182 | LHI CareFusion 303, INC.	Male Luer Vial Access Device	2014-07-21
PMN K140831 | FPA CareFusion 303, INC.	MaxZero	2014-04-18
PMN K123267 | FOZ CareFusion 303, INC.	SurFlash Plus Intravascular Catheter	2013-11-18
PMN K122544 | FOZ CareFusion 303, INC.	SurFlash Intravascular Catheter	2013-11-18
PMN K132413 | FPA CareFusion 303, INC.	MaxZero	2013-11-04
PMN K051930 | FMF CareFusion 303, INC.	Multi-dose vial access spike w/ needleless connector	2012-11-07
PMN K110535 CAREFUSION 303,INC.	ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION	2012-03-26
PMN K110809 CAREFUSION 303, INC.	WIRELESS MONITORING SYSTEM	2011-07-05
PMN K083765 | FPA CareFusion 303, INC.	MaxGuard	2010-12-20
PMN K083472 | FPA CareFusion 303, INC.	MaxPlus	2010-12-20
PMN K072542 | FPA CareFusion 303, INC.	MaxPlus	2010-12-20
PMN K051499 | FPA CareFusion 303, INC.	MaxGuard, MaxPlus	2010-12-20
PMN K970485 | FPA CareFusion 303, INC.	SmartSite Vial Access Device	2008-10-16
PMN K970485 | FPA CareFusion 303, INC.	SmartSite Bag Access device	2008-10-16
PMN K970485 | FPA CareFusion 303, INC.	SmartSite Access Pin	2008-10-16
PMN K960280 | FPA CareFusion 303, INC.	Alaris, SmartSite, VersaSafe, Texium	2008-10-16
PMN K955846 | FLL CareFusion 303, INC.	Turbo Temp Thermometer, Probes, and accessories	2008-10-16
PMN K951922 | FPA CareFusion 303, INC.	Alaris, SmartSite, VersaSafe	2008-10-16
PMN K950419 | FRN CareFusion 303, INC.	Alaris, SmartSite	2008-10-16
PMN K950419 | FPA CareFusion 303, INC.	Alaris, SmartSite	2008-10-16
PMN K945070 | FPA CareFusion 303, INC.	Alaris, VersaSafe	2008-10-16
PMN K944320 | FPA CareFusion 303, INC.	Alaris, SmartSite, VersaSafe, Texium	2008-10-16
PMN K934095 | FPA CareFusion 303, INC.	Alaris	2008-10-16
PMN K933144 | FRN CareFusion 303, INC.	Gemini PUmp PC-2-TX	2008-10-16
PMN K931550 | FPA CareFusion 303, INC.	Alaris, Signature Edition, SmartSite, VersaSafe	2008-10-16
PMN K931549 | FRN CareFusion 303, INC.	Signature Edition Pump	2008-10-16
PMN K931549 | FRN CareFusion 303, INC.	Alaris SE Pump	2008-10-16
PMN K931173 | FPA CareFusion 303, INC.	Alaris, SmartSite, VersaSafe	2008-10-16
PMN K925228 | FPA CareFusion 303, INC.	59 Series Sets	2008-10-16
PMN K924718 | FPA CareFusion 303, INC.	Alaris	2008-10-16
PMN K921378 | FRN CareFusion 303, INC.	Gemini Pump PC-4	2008-10-16
PMN K896914 | FLL CareFusion 303, INC.	Core Check Thermometer	2008-10-16
PMN K894842 | FPA CareFusion 303, INC.	Alaris, SmartSite, VersaSafe	2008-10-16
PMN K882302 | FPA CareFusion 303, INC.	Alaris, SmartSite	2008-10-16
PMN K880479 | FRN CareFusion 303, INC.	Gemini Pump PC-1	2008-10-16
PMN K874564 | FRN CareFusion 303, INC.	MedSystem III, SmartSite	2008-10-16
PMN K874564 | FPA CareFusion 303, INC.	MedSystem III, SmartSite	2008-10-16
PMN K872952 | FRN CareFusion 303, INC.	Alaris Air in Line Sensor	2008-10-16
PMN K862295 | FRN CareFusion 303, INC.	Gemini Pump PC-2 (1320)	2008-10-16
PMN K860436 | FLL CareFusion 303, INC.	Alaris, Turbo Temp, Turbo Temp Plus	2008-10-16
PMN K833033 | FPA CareFusion 303, INC.	IVAC Nitro Set	2008-10-16
PMN K820764 | FRN CareFusion 303, INC.	Air in Line Detector IVAC	2008-10-16
PMN K820409 | FLL CareFusion 303, INC.	Electronic Clinical Thermometer Probes	2008-10-16
PMN K820278 | FPA CareFusion 303, INC.	Alaris, SmartSite, VersaSafe	2008-10-16
PMN K811885 | FPA CareFusion 303, INC.	Alaris, SmartSite	2008-10-16
PMN K811110 | FPA CareFusion 303, INC.	52 Series Sets	2008-10-16
PMN K801614 | FPB CareFusion 303, INC.	In-Line Filter	2008-10-16
PMN K790582 | FPA CareFusion 303, INC.	Alaris, SmartSite, Texium	2008-10-16
PMN K790108 | FPA CareFusion 303, INC.	Alaris, VersaSafe	2008-10-16
PMN K780130 | FPA CareFusion 303, INC.	Alaris, VersaSafe, SmartSite	2008-10-16
PMN K072105 | FRN CareFusion 303, INC.	Alaris System with MMS	2008-10-16
PMN K061285 | FPA CareFusion 303, INC.	Alaris, SmartSite	2008-10-16
PMN K041241 | FRN CareFusion 303, INC.	Alaris/Medley Bar Code Module	2008-10-16
PMN K032233 | MEA CareFusion 303, INC.	Medley PCA Module	2008-10-16
PMN K032233 | MEA CareFusion 303, INC.	Alaris PCA Module	2008-10-16
PMN K032233 | FRN CareFusion 303, INC.	Medley PCA Module	2008-10-16
PMN K032233 | FRN CareFusion 303, INC.	Alaris PCA Module	2008-10-16
PMN K032147 | FRN CareFusion 303, INC.	Signature Edition Instrument	2008-10-16
PMN K032147 | FRN CareFusion 303, INC.	Signature Edition Infusion Sets	2008-10-16
PMN K032147 | FPA CareFusion 303, INC.	Signature Edition Instrument	2008-10-16
PMN K032147 | FPA CareFusion 303, INC.	Signature Edition Infusion Sets	2008-10-16
PMN K030459 | FRN CareFusion 303, INC.	Alaris/Medley System with MMS	2008-10-16
PMN K023264 | FRN CareFusion 303, INC.	Alaris/Medley Syringe Module	2008-10-16
PMN K022677 | DQA CareFusion 303, INC.	Alaris/Medley SpO2 Module	2008-10-16
PMN K013087 | LHI CareFusion 303, INC.	Single Dose Dispensing Pin	2008-10-16
PMN K012383 | FRN CareFusion 303, INC.	Alaris Infusion Pumps Expanded Indications	2008-10-16
PMN K071400 | FMG CareFusion 303, INC.	SmartSite	2008-02-05
PMN K050230 | FLL CareFusion 303, INC.	Tri-Site/Turbo-Temp Trio	2008-02-05
PMN K946168 | LZH CareFusion 303, INC.	Alaris, Signature Edition	2007-11-20
PMN K823018 | FLN CareFusion 303, INC.	Gravity Flow Monitor	2007-11-20
PMN K820569 | DXN CareFusion 303, INC.	Blood Pressure Measurement systems and accessories	2007-11-20
PMN K053049 | FPA CareFusion 303, INC.	Texium/Alaris Safety Male Luer and accessories	2007-11-20
PMN K052790 | LHI CareFusion 303, INC.	SmartSite Vented Vial Access Device	2007-11-20
PMN K051641 | FRN CareFusion 303, INC.	Alaris PC Unit	2007-11-20
PMN K043299 | MEA CareFusion 303, INC.	Alaris PCA	2007-11-20
PMN K031741 | CCK CareFusion 303, INC.	Alaris/Medley EtCO2 Module	2007-11-20
PMN K010966 | DQA CareFusion 303, INC.	Alaris/Medley SpO2 Module	2007-11-20
PMN K050115 | BRZ CareFusion 303, INC.	Blood Hand Pump Administration Set	2007-09-10
BRY CareFusion 303, INC.	ANESTHESIA STATION	2007-09-10
BRY CareFusion 303, INC.	ANESTHESIA STATION(MULTIPLE)	2007-09-10
PMN K961486 | MRZ CareFusion 303, INC.	MSIII Instrument Accessory	2001-07-13
PMN K071108 | FMF CareFusion 303, INC.	VARIOUS TYPES OF PISTON SYRINGES	1992-10-01
PMN K022209 | LHI CareFusion 303, INC.	Alaris products admin sets, extension sets, components, and secondary sets	1992-10-01
PMN K022209 | FPA CareFusion 303, INC.	Alaris products admin sets, extension sets, components, and secondary sets	1992-10-01

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200918294	Sydney,Australia -> Long Beach, California	ON 5 PALLETS POWER CABLES HS CODE 85444221	117 CTN