FDA device listing

Device, Intravascular Catheter Securement

FDA device listing 1653973884 · STERIS Corporation

Key facts

Owner/operator STERIS Corporation
Owner/operator number 1527821
Product codes KMK
Device names KMK - Device, Intravascular Catheter Securement
Device class Class I
Classification regulations (21 CFR) 880.5210
Review panels General Hospital
Registered establishments Isomedix Operations, Inc., ISOMEDIX OPERATIONS INC.
Establishment registrations 1047843, 1220477, 2030624, 2183744
FEI numbers 1047843, 1220477, 2183744, 3000206435
Establishment operations Contract Sterilizer
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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