FDA device listing

Mucaid

FDA device listing 2015178421 · VYGON S A

Key facts

Proprietary names Mucaid
Owner/operator VYGON S A
Owner/operator number 8020785
Premarket submissions K910909
Product codes BSY
Device names BSY - Catheters, Suction, Tracheobronchial
Device class Class I
Classification regulations (21 CFR) 868.6810
Review panels Anesthesiology
Registered establishments Dimequip, VYGON COLOMBIA S.A., VYGON S A, Vygon Verneuil
Establishment registrations 8020785, 3002808467, 3004569180, 3011237770
FEI numbers 3002808467, 3004569180, 3009291251, 3011237770
Establishment operations Contract Sterilizer, 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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