FDA device listing

Closed Suction Catheter; model: (5fr,6fr,7fr,8fr,10fr,12fr,14fr,16fr)

FDA device listing 1540135787 · Kindwell Medical Equipment Co., Ltd

Key facts

Proprietary names Closed Suction Catheter; model: (5fr,6fr,7fr,8fr,10fr,12fr,14fr,16fr)
Owner/operator Kindwell Medical Equipment Co., Ltd
Owner/operator number 10093551
Product codes BSY
Device names BSY - Catheters, Suction, Tracheobronchial
Device class Class I
Classification regulations (21 CFR) 868.6810
Review panels Anesthesiology
Registered establishments Kindwell Medical Equipment Co., Ltd
Establishment registrations 3038632675
FEI numbers 3038632675
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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