FDA device listing

CYTOCARE,i.v.STATION,i.v.STATION ONCO

FDA device listing 2072842515 · Omnicell S.R.L. (HEALTH ROBOTICS)

Key facts

Proprietary names CYTOCARE,i.v.STATION,i.v.STATION ONCO
Owner/operator Omnicell S.R.L. (HEALTH ROBOTICS)
Owner/operator number 9090470
Product codes NEP
Device names NEP - System/Device, Pharmacy Compounding
Device class Class II
Classification regulations (21 CFR) 880.5440
Review panels General Hospital
Registered establishments Omnicell S.R.L.
Establishment registrations 3006153342
FEI numbers 3006153342
Establishment operations Complaint File Establishment, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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