Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBecton Dickinson Infusion Therapy Systems Inc.
United States·US-MF-000017719
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 9450, South State Street, Sandy, United States
- Website
- No website
- —
- —
- [email protected]
- Phone
- +1 801 230 5783
- PRRC Contact
- Nitin Patil
- EUDAMED SRN
- US-MF-000017719
- FDA FEI Number
- 1710034
- DUNS Number
- —
Catalogue (67)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Venflon | 393258 | EUDAMED | Class IIa | Active |
| Venflon | 393245 | EUDAMED | Class IIa | Active |
| Venflon | 393210 | EUDAMED | Class IIa | Active |
| Venflon | 393259 | EUDAMED | Class IIa | Active |
| Venflon | 393239 | EUDAMED | Class IIa | Active |
| Venflon | 393274 | EUDAMED | Class IIa | Active |
| Venflon | 393255 | EUDAMED | Class IIa | Active |
| Venflon | 393232 | EUDAMED | Class IIa | Active |
| Venflon | 393234 | EUDAMED | Class IIa | Active |
| Venflon | 393260 | EUDAMED | Class IIa | Active |
| Venflon | 393275 | EUDAMED | Class IIa | Active |
| Venflon | 393273 | EUDAMED | Class IIa | Active |
| Venflon | 393237 | EUDAMED | Class IIa | Active |
| Venflon | 393228 | EUDAMED | Class IIa | Active |
| Venflon | 393209 | EUDAMED | Class IIa | Active |
| Venflon | 393240 | EUDAMED | Class IIa | Active |
| Venflon | 393202 | EUDAMED | Class IIa | Active |
| Venflon | 393236 | EUDAMED | Class IIa | Active |
| Venflon | 393257 | EUDAMED | Class IIa | Active |
| Venflon | 393276 | EUDAMED | Class IIa | Active |
| Venflon | 393277 | EUDAMED | Class IIa | Active |
| Venflon | 393208 | EUDAMED | Class IIa | Active |
| Venflon | 393238 | EUDAMED | Class IIa | Active |
| PIVO™ Pro Needle-free Blood Collection Device | K230865 | FDA 510(k) | Class II | Active |
| PIVO™ Pro Needle-free Blood Collection Device | K241586 | FDA 510(k) | Class II | Active |
| Insyte Catheter, Insyte Autoguard Catheter | K000235 | FDA 510(k) | Class II | Active |
| Bd Saf-T Prn Luer Activated Valve, Model 385100 | K013621 | FDA 510(k) | Class II | Active |
| Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima And Saf-T-Intima Intravascular Catheters | K013073 | FDA 510(k) | Class II | Active |
| Bd Intima Ii Closed Iv Catheter | K143610 | FDA 510(k) | Class II | Active |
| Bd Introsyte Precision Introducer, Bd Introsyte Autogaurd Shielded Introducer | K013304 | FDA 510(k) | Class I | Active |
| BD Nexiva Closed IV Catheter System | K183399 | FDA 510(k) | Class II | Active |
| BD Saf-T-Intima™ Subcutaneous Catheter System | K251422 | FDA 510(k) | Class II | Active |
| Nexiva Closed Iv Catheter System | K032843 | FDA 510(k) | Class II | Active |
| BD Cathena™ Safety IV Catheter | K251155 | FDA 510(k) | Class II | Active |
| Bd Nexiva Closed Iv Catheter System | K102520 | FDA 510(k) | Class II | Active |
| Bd Intima Ii Closed Iv Catheter | K100775 | FDA 510(k) | Class II | Active |
| First Midcath Catheter | K972254 | FDA 510(k) | Class II | Active |
| First Picc Catheter | K972262 | FDA 510(k) | Class II | Active |
| First Picc Catheter With Dual Lumens | K972263 | FDA 510(k) | Class II | Active |
| BD Cathena Safety IV Catheter | K220584 | FDA 510(k) | Class II | Active |
| BD Cathena (TM) Safety IV Catheter | K192493 | FDA 510(k) | Class II | Active |
| BD Angiocath IV Catheter, BD Insyte IV Catheter | K151698 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Introsyte Catheter | K974764 | FDA 510(k) | Class II | Active |
| BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems | K161777 | FDA 510(k) | Class II | Active |
| BD Cathena Safety IV Catheter | K201717 | FDA 510(k) | Class II | Active |
| BD Insyte™ IV Catheter | K252137 | FDA 510(k) | Class II | Active |
| BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | K251654 | FDA 510(k) | Class II | Active |
| BD Nexiva™ Closed IV Catheter System | K243403 | FDA 510(k) | Class II | Active |
| Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima, And Saf-T-Intima Intravascular Cathete | K013800 | FDA 510(k) | Class II | Active |
| Bd Nexiva Diffusics Closed Iv Catheter System | K123734 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (15)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 21, 2025 | Z-2003-2025 | — | open, classified | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Z-2002-2025 | — | open, classified | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Z-1999-2025 | — | open, classified | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Z-2007-2025 | — | open, classified | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Z-2000-2025 | — | open, classified | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Z-2004-2025 | — | open, classified | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Z-2005-2025 | — | open, classified | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Z-2001-2025 | — | open, classified | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| May 21, 2025 | Z-2006-2025 | — | open, classified | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. |
| Apr 21, 2025 | Z-1808-2025 | — | open, classified | Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay. |
| Jun 26, 2024 | Z-2458-2024 | — | open, classified | Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process. |
| Oct 4, 2023 | Z-0400-2024 | — | open, classified | Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site. |
| Aug 29, 2023 | Z-0025-2024 | — | open, classified | There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed. |
| Oct 12, 2022 | Z-0174-2023 | — | open, classified | During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed). |
| Sep 8, 2021 | Z-0306-2022 | — | open, classified | There is a breach in the product packaging that renders the product non-sterile. |