FDA device listing

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

FDA device listing 1757525567 · Cardinal Health 200, LLC

Key facts

Owner/operator Cardinal Health 200, LLC
Owner/operator number 9028292
Product codes GCY
Device names GCY - Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device class Class I
Classification regulations (21 CFR) 878.4680
Review panels General & Plastic Surgery
Registered establishments Cardinal Health, Cardinal Health 200, LLC, CARDINAL HEALTH 200, LLC, Cardinal Health (Kenmex Medical Specialties), CARDINAL HEALTH P.R. 218, INC., Convertors de Mexico S. de R.L. de C.V
Establishment registrations 1423537, 1623486, 1921846, 2640138, 9612030, 9616088, 3007329020
FEI numbers 1623486, 1921846, 3001236905, 3002806934, 3002902735, 3003370911, 3007329020
Establishment operations Complaint File Establishment, Manufacturer, Repackager/Relabeler, 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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