FDA device listing

BAXTER

FDA device listing 1305855918 · TAM VIET DISTRIBUTION COMPANY LIMITED

Key facts

Proprietary names BAXTER
Owner/operator TAM VIET DISTRIBUTION COMPANY LIMITED
Owner/operator number 10059849
Premarket submissions K993120
Product codes BRZ
Device names BRZ - Set, Blood Transfusion
Device class Class II
Classification regulations (21 CFR) 880.5440
Review panels General Hospital
Registered establishments TAM VIET DISTRIBUTION COMPANY LIMITED
Establishment registrations 3015276780
FEI numbers 3015276780
Establishment operations Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 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

Browse all FDA device listings