FDA device listing

5-LITER Oxygen Concentrator,A5LC1; JUMAO,BES-OC17,OC5L Oxygen Concentrator 5 Liter

FDA device listing 1990385428 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd

Key facts

Proprietary names 5-LITER Oxygen Concentrator,A5LC1; JUMAO,BES-OC17,OC5L Oxygen Concentrator 5 Liter
Owner/operator Jiangsu Jumao X-Care Medical Equipment Co., Ltd
Owner/operator number 10058053
Premarket submissions K090007
Product codes CAW
Device names CAW - Generator, Oxygen, Portable
Device class Class II
Classification regulations (21 CFR) 868.5440
Review panels Anesthesiology
Registered establishments JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD
Establishment registrations 3014810929
FEI numbers 3014810929
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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