Data / Medical devices / Mexico / BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V.
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V.: FDA-registered device maker in NOGALES Sonora, Mexico, 15 510(k) clearances
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V. is registered with the FDA (registration 9610847) in NOGALES Sonora, Mexico. It lists 13 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9610847
- FEI number
- 3002879021
- Address
- PERIFERICO LUIS DONALDO COLOSIO No. 579, NOGALES Sonora, Mexico, 84048
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 3, 2001
- Registered through
- 2026
- Brand names listed
- BD Alaris Infusion Set, BD Alaris Pump Infusion Set, BD Angiocath IV Catheter, BD Epilor Syringe, BD Hypodermic Needles, BD Hypodermic Syringe, BD Insyte IV Catheter, BD Integra and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anesthesia Conduction Kit | CAZ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| I.V. Start Kit | LRS | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Contract manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Contract manufacturer | accessdata.fda.gov |
| Stopcock, I.V. Set | FMG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 21, 2023 | K221327 | BD Alaris Pump Infusion Sets | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| May 19, 2022 | K210983 | BD Epilor Syringe | CAZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 27, 2016 | K161170 | BD Eclipse Hypodermic Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 27, 2015 | K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| September 19, 2014 | K142527 | Extension Set with BD Q-Syte Luer Access Split Septum | FPA | Substantially Equivalent | Acacia, Inc. | accessdata.fda.gov |
| July 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | Substantially Equivalent | Bd | accessdata.fda.gov |
| April 16, 2002 | K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 | FPA | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| June 13, 2001 | K011103 | BD SPRING BASED SYRINGE | MEG | Substantially Equivalent | Bd | accessdata.fda.gov |
| March 1, 2001 | K010188 | BD ECLIPSE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | Bd Medical Systems | accessdata.fda.gov |
| October 1, 1999 | K992734 | BECTON DICKINSON SYRINGE | MEG | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| June 11, 1998 | K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 13, 1998 | K974083 | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS | FMG | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| October 7, 1995 | K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 14, 1993 | K925902 | B-D LOSS OF RESISTANCE SYRINGE | CAZ | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 29, 1979 | K790582 | INTRAVASCULAR ADMINISTRATION SET | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Set, Administration, Intravascular
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Anesthesia Conduction Kit
Updated July 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.