FDA device listing

HubGuard,Medline SeeIV,Secureview,SorbaView,SorbaView 2000,SorbaView SHIELD

FDA device listing 1436648814 · Medline Industries, LP

Key facts

Proprietary names HubGuard,Medline SeeIV,Secureview,SorbaView,SorbaView 2000,SorbaView SHIELD
Owner/operator Medline Industries, LP
Owner/operator number 1417592
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 Medline Canada, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - Northfield, MEDLINE INDUSTRIES, LP (Northpoint Services), Medline Operations Germany GMBH
Establishment registrations 1417592, 1422634, 3007289408, 3012543139, 3015173212
FEI numbers 1417592, 1000514656, 3007289408, 3012543139, 3015173212
Establishment operations Contract Sterilizer, 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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