FDA device listing

Swiss Safe First Aid Kit

FDA device listing 1148265300 · HYDY, Inc.

Key facts

Proprietary names Swiss Safe First Aid Kit
Owner/operator HYDY, Inc.
Owner/operator number 10082377
Product codes OHO
Device names OHO - First Aid Kit Without Drug
Device class Class I
Classification regulations (21 CFR) 878.4014
Review panels General & Plastic Surgery
Registered establishments Sargas LLC/ Sabik LLC/ Karaka LLC/Archernar LLC
Establishment registrations 3019804885
FEI numbers 3019804885
Establishment operations 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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