FDA device listing

Q Flo Valve assembly

FDA device listing 1894095704 · NOVEM MEDICAL S. DE R.L. DE C.V.

Key facts

Proprietary names Q Flo Valve assembly
Owner/operator NOVEM MEDICAL S. DE R.L. DE C.V.
Owner/operator number 10049894
Product codes FPA
Device names FPA - Set, Administration, Intravascular
Device class Class II
Classification regulations (21 CFR) 880.5440
Review panels General Hospital
Registered establishments NOVEM MEDICAL S. DE R.L. DE C.V.
Establishment registrations 3012187635
FEI numbers 3012187635
Establishment operations Contract Manufacturer
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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