FDA device listing

Mattress Cover,Seating Cushion Cover,Stretcher Pad Cover

FDA device listing 1381989847 · JOERNS HEALTHCARE LLC

Key facts

Proprietary names Mattress Cover,Seating Cushion Cover,Stretcher Pad Cover
Owner/operator JOERNS HEALTHCARE LLC
Owner/operator number 9105099
Product codes FMW
Device names FMW - Cover, Mattress (Medical Purposes)
Device class Class I
Classification regulations (21 CFR) 880.6190
Review panels General Hospital
Registered establishments Joerns Healthcare, Joerns Healthcare Brownsville
Establishment registrations 3009402404, 3012392312, 3018084435
FEI numbers 3009402404, 3012392312, 3018084435
Establishment operations Complaint File Establishment, Specification Developer, 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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