Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003152976

FEI Number

3003152976

Entity Name

BECTON DICKINSON, S.A.

City/State/Country

SAN AGUSTIN DE GUADALIX Madrid (Province), ES

Establishment Address

CAMINO DE VALDEOLIVIA, S/N, SAN AGUSTIN DE GUADALIX Madrid (Province) 28750, ES

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Becton Dickinson and Company (Owner Number: 9922032)

Owner / Operator Contact Address

One Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BD PhaSeal Optima Infusion Clamp BD Whitacre Spinal NRFit Needle BD Spinal Introducer NRFit Needle BD Quincke Spinal NRFit Needle BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE PhaSeal: Connector Luer Lock, C35, C45 PhaSeal: Injector Luer Lock, N35, N35C, N35C Multi PhaSeal: Cap for Injector, M50 BD Quincke Spinal Needle BD Spinal Introducer Needle BD Whitacre Spinal Needle BD Perisafe Tuohy Epidural Needle BD Perisafe Weiss Epidural Needle BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 PhaSeal: Hanger for IV Bag, M55 BD Spinal Needle BD Hypodermic Syringe BD Plastipak Syringe BD PhaSeal Optima Connecting Set (C83-O) BD PhaSeal Optima Spike Set (C180-O)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2013-01-11
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2020-12-04
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2013-02-26
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2012-05-31
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2022-06-13
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2022-07-01
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2013-03-06
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2013-01-11
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2013-08-26
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-04
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-08-06
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2025-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

John Roberts Email: john_w_roberts@bd.com Phone: (201) 8474760

Related Public Records

Same Entity

Becton Dickinson and Company

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680577	BECTON DICKINSON GMBH	HEIDELBERG Baden-Wurttemberg, DE
3003916417	BECTON DICKINSON IND. CIRURGICAS LTDA.	CURITIBA Parana, BR
3036495171	BD Biosciences San Diego	San Diego, CA, US
3015292643	BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES	San Diego, CA, US
3010141591	BD Kiestra B.V.	Drachten Fryslan, NL

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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
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-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003152976. Last updated year: 2026. Please use registration number 3003152976 when referencing this establishment in official correspondence.