Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003879246

FEI Number

3003879246

Entity Name

CareFusion 303, INC

City/State/Country

San Diego, CA, US

Establishment Address

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

Establishment Type(s)

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

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

K010966

PMA Number

N/A

All Registered Proprietary Names

Alaris PCA 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 Alaris PC Unit 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

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
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
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2007-11-20
BRY	Cabinet, Table And Tray, Anesthesia	Anesthesiology	Class 1	868.6100	2007-09-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2007-11-20

Official Correspondent

Darin Oppenheimer

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
2016493	CareFusion 303, INC.	SAN DIEGO, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
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.

Similar Registrations

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2016493	CareFusion 303, INC.	SAN DIEGO, CA, US
3010381606	EMSERE BV	Leiden Zuid-Holland, NL
3012337868	InfuSystem Inc.	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003879246. Last updated year: 2026. Please use registration number 3003879246 when referencing this establishment in official correspondence.