FDA device listing

URINE DRAINAGE BAG

FDA device listing 1250124000 · NINGBO GREATCARE TRADING CO., LTD.

Key facts

Proprietary names URINE DRAINAGE BAG
Owner/operator NINGBO GREATCARE TRADING CO., LTD.
Owner/operator number 9102181
Product codes KNX
Device names KNX - Collector, Urine, (And Accessories) For Indwelling Catheter
Device class Class II
Classification regulations (21 CFR) 876.5250
Review panels Gastroenterology & Urology
Registered establishments Ningbo Greatcare Medical Instruments Co., Ltd.
Establishment registrations 3006552462
FEI numbers 3006552462
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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