FDA device listing

GENOSYL DS Mixer

FDA device listing 1664728941 · C2C Development, LLC

Key facts

Proprietary names GENOSYL DS Mixer
Owner/operator C2C Development, LLC
Owner/operator number 10047566
Product codes MRN
Device names MRN - Apparatus, Nitric Oxide Delivery
Device class Class II
Classification regulations (21 CFR) 868.5165
Review panels Anesthesiology
Registered establishments C2C DEVELOPMENT, LLC
Establishment registrations 3011193444
FEI numbers 3011193444
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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