FDA device listing

Sunset Nasal Gel Pad

FDA device listing 1393972544 · Sunset Healthcare Solutions

Key facts

Proprietary names Sunset Nasal Gel Pad
Owner/operator Sunset Healthcare Solutions
Owner/operator number 9106379
Product codes FMP
Device names FMP - Protector, Skin Pressure
Device class Class I
Classification regulations (21 CFR) 880.6450
Review panels General Hospital
Registered establishments Sunset Healthcare Solutions Central Warehouse, SUNSET HEALTHCARE SOLUTIONS, Inc., SUNSET HEALTHCARE SOLUTIONS Warehouse
Establishment registrations 3006446479, 3010834934, 3021244152
FEI numbers 3006446479, 3010834934, 3021244152
Establishment operations Complaint File Establishment, 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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