FDA device listing

Cannula, Nasal, Oxygen; Nasal Cannula; Nasal Oxygen Cannula; Capnography CO2 Sample Line

FDA device listing 1364543976 · BOEN HEALTHCARE CO., LTD.

Key facts

Proprietary names Cannula, Nasal, Oxygen; Nasal Cannula; Nasal Oxygen Cannula; Capnography CO2 Sample Line
Owner/operator BOEN HEALTHCARE CO., LTD.
Owner/operator number 10095691
Product codes CAT
Device names CAT - Cannula, Nasal, Oxygen
Device class Class I
Classification regulations (21 CFR) 868.5340
Review panels Anesthesiology
Registered establishments BOEN HEALTHCARE CO., LTD.
Establishment registrations 3045058049
FEI numbers 3045058049
Establishment operations Foreign Exporter, 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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