FDA device listing

Becton, Dickinson and Company

FDA device listing 1254537850 · J. KNIPPER AND COMPANY, INC.

Key facts

Proprietary names Becton, Dickinson and Company
Owner/operator J. KNIPPER AND COMPANY, INC.
Owner/operator number 9053305
Premarket submissions K161553
Product codes FMI
Device names FMI - Needle, Hypodermic, Single Lumen
Device class Class II
Classification regulations (21 CFR) 880.5570
Review panels General Hospital
Registered establishments J. Knipper and Company, Inc.
Establishment registrations 3014680791
FEI numbers 3014680791
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 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

Browse all FDA device listings