FDA device listing

BD Ready-to-Use Hydrophilic Catheter,Ready-to-Use Hydrophilic Catheter

FDA device listing 1592017726 · Xianju Bever Medical Devices Co., Ltd.

Key facts

Proprietary names BD Ready-to-Use Hydrophilic Catheter,Ready-to-Use Hydrophilic Catheter
Owner/operator Xianju Bever Medical Devices Co., Ltd.
Owner/operator number 10090117
Product codes EZD, GBM
Device names EZD - Catheter, Straight, GBM - Catheter, Urethral
Device class Class II
Classification regulations (21 CFR) 876.5130
Review panels Gastroenterology & Urology
Registered establishments XIANJU BEVER MEDICAL DEVICES CO., LTD.
Establishment registrations 3030671614
FEI numbers 3030671614
Establishment operations Contract 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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