Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012798826

FEI Number

3012798826

Entity Name

BD SWITZERLAND SARL

City/State/Country

Eysins Vaud, CH

Establishment Address

Terre Bonne Park - A4 Route de Crassier 17, Eysins Vaud 1262, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CareFusion (Owner Number: 10062808)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221327

PMA Number

N/A

All Registered Proprietary Names

BD SmartSite Vial Access Device set, administration, intravascular BD Male/Female Luer Lock Cap k083472 set, administration, intravascular BD PhaSeal set, administration, intravascular BD Alaris Pump Infusion Set k022209 set, administration, intravascular set, administration, intravascular set, administration, intravascular BD PhaSeal set, administrative, intravascular set, administration, intravascular Texium set, administration, intravascular Stopcock, IV, Set set, administration, intravascular Set, adminiastration, intravascular k132413 set, administration, intravascular set, administration, intravascular Stand, Infusion BD Texium Needle-Free Syringe set, administration, intravascular BD Alaris Infusion Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2020-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-10-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2024-06-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-05-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-05-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2020-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2024-06-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-05-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2020-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2024-11-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-02-05
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2024-02-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-08-11

Official Correspondent

Angela Caravella

US Agent Details

Angela Caravella Business: BD Switzerland Email: angela.caravella@bd.com Phone: (201) 5746985

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
9616066	SISTEMAS MEDICOS ALARIS, S.A De C.V.	TIJUANA Baja California, MX
3012410077	CAREFUSION	San Diego, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
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

Similar Registrations

Registration Number	Establishment Name	Location
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3042177665	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
2032098	Isomedix Operations, Inc	ONTARIO, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012798826. Last updated year: 2026. Please use registration number 3012798826 when referencing this establishment in official correspondence.