FDA device listing

Foam Patient Positioning

FDA device listing 1697265565 · O&M Halyard, Inc.

Key facts

Proprietary names Foam Patient Positioning
Owner/operator O&M Halyard, Inc.
Owner/operator number 10057479
Product codes CCX
Device names CCX - Support, Patient Position
Device class Class I
Classification regulations (21 CFR) 868.6820
Review panels Anesthesiology
Registered establishments O&M Halyard, Inc.
Establishment registrations 3014421917
FEI numbers 3014421917
Establishment operations Complaint File Establishment, Manufacturer, 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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