Establishment registration

Outset Medical, Inc.

FDA establishment registration 3010355846 · San Jose, US

Key facts

Registration number 3010355846
Establishment name Outset Medical, Inc.
Owner/operator Outset Medical, Inc.
Owner/operator number 10047467
FEI number 3010355846
Address 3052 Orchard Drive
City San Jose
State CA
Country US
Registration valid through 2026
Product codes listed FIP, FJK, KDI
Device classes 2

At a glance

  • 1–9 Device listings
  • 100–999 UDI devices (GUDID)
  • Current Registration current
  • 1–9 FDA inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device establishment registrations

Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device establishment registrations