FDA device listing

SCOUT Console and Accessory Cart

FDA device listing 1389321787 · Merit Medical Systems, Inc.

Key facts

Proprietary names SCOUT Console and Accessory Cart
Owner/operator Merit Medical Systems, Inc.
Owner/operator number 1721504
Product codes BZN
Device names BZN - Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Device class Class I
Classification regulations (21 CFR) 868.6175
Review panels Anesthesiology
Registered establishments Merit Medical Asia Company Limited, Merit Medical Australia Pty Ltd., Merit Medical Canada Ltd., Merit Medical Nederland BV, Merit Medical Systems, Inc., MERIT MEDICAL SYSTEMS, INC., Merit Medical UK Limited
Establishment registrations 1721504, 2032338, 3006950086, 3012536737, 3015225571, 3015309643, 3033589330
FEI numbers 1721504, 3003295907, 3006950086, 3012536737, 3015225571, 3015309643, 3033589330
Establishment operations Complaint File Establishment, Foreign Exporter, Specification Developer
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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