Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610847

FEI Number

3002879021

Entity Name

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V.

City/State/Country

NOGALES Sonora, MX

Establishment Address

PERIFERICO LUIS DONALDO, COLOSIO No. 579, NOGALES Sonora 84048, MX

Establishment Type(s)

Manufacture Medical Device

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

K790582

PMA Number

N/A

All Registered Proprietary Names

Extension Set with BD Q-Syte Luer Access Split Septum Connecta Stopcock IV Set BD SafetyGlide Needle BD Introsyte Autoguard BD Intosyte BD Alaris Pump Infusion Set BD Hypodermic Syringe BD Angiocath IV Catheter BD Saf-T-Intima Safety System Nexiva Closed IV Catheter System with NearPort IV Access IV Start Kit Eclipse Needle Q-Syte Luer Access Device SAPPHIRE INFUSION PUMP Set SURE-MED TAMPER TUF Tip cap CORNWALL Eclipse Gemini Sets, Medley Pump Sets, Alaris Pump Sets Safetyglide Syringe BD SafetyGlde Insulin Syringe BD Epilor Syringe BD Alaris Infusion Set BD Insyte IV Catheter BD Angiocath IV Catheter BD Insyte IV Catheter BD Angiocath IV Catheter BD Hypodermic Needles BD PrecisionGlide Needle BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector BD Integra Secondary Sets

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	2014-10-20
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2008-02-26
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-02-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-05-08
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-05-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-04
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-01-12
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
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2016-01-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-02-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-07-29
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2020-07-29
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2001-08-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-08-01
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-10-05
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2007-12-07
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2022-06-10
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-08-11
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	2016-04-15
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2008-02-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-02-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-02-19
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-01-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-02-19
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2008-02-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-10-05

Official Correspondent

No official correspondent registered.

US Agent Details

Christopher Rogers Email: christopher.rogers2@bd.com Phone: (201) 5746485

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
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-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610847. Last updated year: 2026. Please use registration number 9610847 when referencing this establishment in official correspondence.