FDA device listing

Adjustable Mask,Venturi Mask

FDA device listing 1806156754 · HUZHOU JUNDA INDUSTRY CO., LTD.

Key facts

Proprietary names Adjustable Mask,Venturi Mask
Owner/operator HUZHOU JUNDA INDUSTRY CO., LTD.
Owner/operator number 10092052
Product codes BYF
Device names BYF - Mask, Oxygen, Low Concentration, Venturi
Device class Class I
Classification regulations (21 CFR) 868.5600
Review panels Anesthesiology
Registered establishments HUZHOU JUNDA INDUSTRY CO., LTD.
Establishment registrations 3034669683
FEI numbers 3034669683
Establishment operations Contract Manufacturer, Foreign Exporter, 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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