Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2016493

FEI Number

2016493

Entity Name

CareFusion 303, INC.

City/State/Country

SAN DIEGO, CA, US

Establishment Address

10020 Pacific Mesa Blvd, SAN DIEGO, CA 92121, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

CareFusion 303, INC. (Owner Number: 9068764)

Owner / Operator Contact Address

3750 Torrey View Ct, --, San Diego, CA 92130, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243855

PMA Number

N/A

All Registered Proprietary Names

Alaris PCA Alaris/Medley EtCO2 Module BD Pyxis Anesthesia Station ES BD Pyxis MedStation 4000 BD Pyxis MedBank Tower BD Pyxis Medflex 2000 BD Pyxis MedStation ES Tower BD Pyxis MedBank Tower Auxiliary BD Pyxis Medflex 1000 BD Pyxis MedStation ES BD Pyxis Med Auxiliary (AUX) BD Pyxis Med Auxiliary (AUX) Tower BD Pyxis MedBank Mini BD Pyxis Anesthesia Station 4000 BD Pyxis MedBank Mini Auxiliary BD Pyxis ES Refrigerator BD Pyxis Pro MedStation Dispensing System BD Pyxis MedStation 4000 Integrated Main BD Pyxis MedBank CUBIE Replenishment Station BD Pyxis CUBIE System BD Pyxis Enterprise Server Alaris/Medley SpO2 Module Alaris System with MMS Alaris/Medley Syringe Module Alaris/Medley SpO2 Module Alaris System with Guardrails Suite MX Alaris/Medley Bar Code Module BD Alaris PCU Module, Model 8015 BD Alaris Infusion Adapter Software Alaris Guardrails Editor Software BD Alaris System Manager 9601, Software BD Alaris Syringe Module, Model 8110 BD Alaris Pump Module, Model 8100 BD Alaris ETC02 Module, Model 8300 Alaris System Maintenance Software Alaris PCA Module, Model 8120 BD Alaris Calculation Services, Software BD Alaris System with Guardrails Suite Software Alaris Auto-ID Module BD Alaris Auto-ID Module BD Alaris PC Unit BD Alaris Pump Module, Model 8100 BD Alaris Calculation Services, Software BD Alaris System Maintenance Software BD Alaris PCU Module, Model 8015, Software BD Alaris PCU Module, Model 8015 Alaris System Maintenance Software Alaris Guardrails Editor Software BD Alaris Infusion Adapter Software BD Alaris ETCO2 Module, Model 8300 BD Alaris Syringe Module, Model 8110, Software Alaris PCA Module, Model 8120, Software BD Alaris System with Guardrails Suite MX BD Alaris ETC02 Module, Model 8300, Software BD Alaris Pump Module, Model 8100, Software BD Alaris Syringe Module, Model 8110

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2007-11-20
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-20
BRY	Cabinet, Table And Tray, Anesthesia	Anesthesiology	Class 1	868.6100	2007-09-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-10-16
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-10-16
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-10-16
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2007-11-20
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2016-04-26
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-10-16
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2023-08-15
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2023-08-15
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2023-08-15
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-08-15
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2025-09-04
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2025-09-04
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2025-09-04
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-09-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CareFusion 303, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3024706751	Sistemas Medicos Alaris S.A de C.V.	Tijuana Baja California, MX
3003879246	CareFusion 303, INC	San Diego, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Z-0026-2018	CareFusion 303, Inc.	2	Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
Z-0035-2026	CareFusion 303, Inc.	2	BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites 10012645, Back Check Valve, Non-vented, SmartSite Y-site 2426-0500, Back Check Valve, 3 SmartSite Y-sites 2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite Y-sites 11522558, Ball Valve, Back Check Valve, 3 SmartSite Y-sites 2410-0500, 2 SmartSite Y-Sites 2232-0007, 0.2 Micron Filter 11613191, 0.2 Micron Filter, Ball Valve, SmartSite" Port (Burette), 2 SmartSite Y-sites 10012144, 3 SmartSite Y-Sites, Check Valve 10013034, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 4-way Stopcock 10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site 11582773, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 3-way Stopcock
Z-0004-2012	Smiths Medical ASD, Inc.	2	Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion.
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01

Similar Registrations

Registration Number	Establishment Name	Location
9615050	ICU Medical Costa Rica Ltd.	La Aurora de Heredia, CR
3004906872	InfuSystem Inc.	Lenexa, KS, US
3010381606	EMSERE BV	Leiden Zuid-Holland, NL
3003879246	CareFusion 303, INC	San Diego, CA, US
3012337868	InfuSystem Inc.	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2016493. Last updated year: 2026. Please use registration number 2016493 when referencing this establishment in official correspondence.