FDA Registration
Active
🇺🇸 United States
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
Reg #: 1710034
·
FEI: 1710034
·
Expires 2026
Products
8
Proprietary Names
32
Establishment Types
4
Classifications
8
Registration Details
- Registration Name
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Registration Number
- 1710034
- FEI Number
- 1710034
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 9450 South State Street
- City
- Sandy
- State
- UT
- ZIP
- 84070
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231239
Owner / Operator
- Firm Name
- Becton Dickinson and Company
- Operator Number
- 9922032
- Address
- One Becton Drive
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2023-09-25 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2023-09-25 |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | Class 2 | General Hospital | No | 2023-12-08 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2021-01-27 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 1991-07-12 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2008-01-07 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2016-01-12 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-11-20 |
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 Saf-T-Intima Subcutaneous Catheter System
IV Start Kit
Interlink Vial Access Cannula
Extension Set with BD Q-Syte Luer Access Split Septum
Q-Syte Luer Access Device
PIVO Pro Needle-free Blood Collection Device
BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder
BD Vacutainer® Push Button Blood Collection Set
BD Insyte Autoguard BC Pro Shielded IV Catheter
BD Insyte Autoguard BC Shielded IV Catheter
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)