FDA device listing

BD Angiocath™ IV Catheter,BD Saf-T-Intima™ Safety System

FDA device listing 1079066318 · Becton Dickinson and Company

Key facts

Proprietary names BD Angiocath™ IV Catheter,BD Saf-T-Intima™ Safety System
Owner/operator Becton Dickinson and Company
Owner/operator number 9922032
Premarket submissions K013800
Product codes FOZ
Device names FOZ - Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class Class II
Classification regulations (21 CFR) 880.5200
Review panels General Hospital
Registered establishments BECTON DICKINSON INFUSION THERAPY SYSTEMS INC., BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V., Becton Dickinson Medical Devices Co., Ltd. Suzhou
Establishment registrations 1710034, 9610847, 3002601200
FEI numbers 1710034, 3002601200, 3002879021
Establishment operations Contract Manufacturer, Contract Sterilizer, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 10–99 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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