Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1710034

FEI Number

1710034

Entity Name

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.

City/State/Country

Sandy, UT, US

Establishment Address

9450 South State Street, Sandy, UT 84070, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K251422

PMA Number

N/A

All Registered Proprietary Names

Nexiva Closed IV Catheter System with NearPort IV Access ExT Extension Set BD Cathena Safety IV Catheter BD Neoflon Pro Safety IV Catheter Texium Closed Male Luer BD Nexiva Diffusics Closed IV Catheter System BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology BD Insyte Autoguard Shielded IV Catheter BD Insyte Autoguard BC Pro Shielded IV Catheter with Blood Control Technology McKesson IV Safety Catheter BD Nexiva Closed IV Catheter System BD Introsyte Autoguard BD Intosyte Insyte Introducer Catheter SPONGE E-Z SCRUB BRUSH BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector BD Angiocath IV Catheter BD Saf-T-Intima Safety System Interlink Blunt Plastic Cannula Twinpak BD Insyte IV Catheter BD Nexiva Diffusics Closed IV Catheter System BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector BD Insyte IV Catheter BD Angiocath IV Catheter BD Saf-T-Intima Subcutaneous Catheter System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2023-09-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-09-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-11-10
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-07-13
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2023-12-08
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2018-03-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2021-01-27
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2021-01-27
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2019-03-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-02-16
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-20
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	1991-07-12
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-01-09
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-01-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-01-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-03-05
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-05-18
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-07-01
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-04-15
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
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-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1710034. Last updated year: 2026. Please use registration number 1710034 when referencing this establishment in official correspondence.