CAREFUSION

FDA Device Registration & Listing · San Diego, CA, US · Registration 3012410077

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012410077
FEI Number
3012410077
Entity Name
CAREFUSION
City/State/Country
San Diego, CA, US
Establishment Address
3750 Torrey View Court, San Diego, CA 92130, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
CareFusion (Owner Number: 10069801)
Owner / Operator Contact Address
3750 Torrey View Court, San Diego, CA 92130, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K061285
PMA Number
N/A

All Registered Proprietary Names

set, adminitration, intravascular set, administration, intravascular BD Texium™ Needle-Free Syringe Secondary Set BD Alaris Infusion Set set, administration, intravascular Interlink Vial Access Cannula Set, administration, intravascular Gravity Set Set, administration, intravascular BD SmartSite Vial Access Device set, administration, intravascular Texium set, administration, intravascular set, administration, intravascular BD SmartSite Gravity Blood Set BD Alaris Pump Infusion Set Q-Syte Luer Access Device set, administration, intravascular Twinpak Interlink Blunt Plastic Cannula Blood Collection Assembly set, administration, intravascular set, administration, intravascular

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-14
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-15
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2024-02-05
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-02-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-14
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-08-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-14
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-05-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-14
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-14
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-14
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2024-03-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-15
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-04-21
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-04-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-15
BRZ Set, Blood Transfusion General Hospital Class 2 880.5440 2020-04-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-05-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-05-16
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-15
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-05-18
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-05-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-15

Official Correspondent

Angela Caravella

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CareFusion
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012798826 BD SWITZERLAND SARL Eysins Vaud, CH
9616066 SISTEMAS MEDICOS ALARIS, S.A De C.V. TIJUANA Baja California, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012410077. Last updated year: 2026. Please use registration number 3012410077 when referencing this establishment in official correspondence.
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