FDA device listing

CO2 NASAL CANNULA - INFANT, M2746A (3768INF-00),CO2 NASAL CANNULA - PEDIATRIC, M2745A (3768PED-00)

FDA device listing 2019450898 · NextPhase Medical Devices LLC Mexico

Key facts

Proprietary names CO2 NASAL CANNULA - INFANT, M2746A (3768INF-00),CO2 NASAL CANNULA - PEDIATRIC, M2745A (3768PED-00)
Owner/operator NextPhase Medical Devices LLC Mexico
Owner/operator number 10046837
Product codes MHX
Device names MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class Class II
Classification regulations (21 CFR) 870.1025
Review panels Cardiovascular
Registered establishments NextPhase Medical Devices Mexico LLC
Establishment registrations 3010882708
FEI numbers 3010882708
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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