FDA device listing

FLOW METER for Oxygen Concentrator

FDA device listing 1897352825 · Danyang Xinya Valve Co., Ltd.

Key facts

Proprietary names FLOW METER for Oxygen Concentrator
Owner/operator Danyang Xinya Valve Co., Ltd.
Owner/operator number 10033907
Product codes BXY
Device names BXY - Flowmeter, Calibration, Gas
Device class Class I
Classification regulations (21 CFR) 868.2350
Review panels Anesthesiology
Registered establishments DANYANG XINYA VALVE CO., LTD.
Establishment registrations 3008281139
FEI numbers 3008281139
Establishment operations Contract Manufacturer, 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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