FDA device listing

Device, Intravascular Catheter Securement

FDA device listing 1951162560 · Zien Medical Technologies LLC

Key facts

Owner/operator Zien Medical Technologies LLC
Owner/operator number 10047676
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 ZIEN MEDICAL TECHNOLOGIES LLC
Establishment registrations 3009756153
FEI numbers 3009756153
Establishment operations Contract Manufacturer, Manufacturer
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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