FDA device listing

Medline Cardiovascular Procedure Kit

FDA device listing 1982425293 · Medline Industries, LP

Key facts

Proprietary names Medline Cardiovascular Procedure Kit
Owner/operator Medline Industries, LP
Owner/operator number 1417592
Product codes OEZ
Device names OEZ - Cardiovascular Procedure Kit
Device class Class II
Classification regulations (21 CFR) 870.1200
Review panels Cardiovascular
Registered establishments Medline Canada, MEDLINE INDUSTRIES, LP - Laredo, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP (Northpoint Services), MEDLINE INDUSTRIES, LP - SPT, Medline Industries (NAMIC Division) - Glen Falls, Medline Soluciones Medicas, PRODUCTOS MEDLINE S.A. DE C.V.
Establishment registrations 1422634, 1423395, 3004122598, 3005595283, 3007289408, 3015173212, 3015910259, 3045816902
FEI numbers 1000514656, 3000717925, 3004122598, 3005595283, 3007289408, 3015173212, 3015910259, 3045816902
Establishment operations Contract Sterilizer, Manufacturer, Foreign Exporter, Repackager/Relabeler
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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