FDA device listing

CPR face shield

FDA device listing 1390745436 · Exin Medical Technology Company, LLC

Key facts

Proprietary names CPR face shield
Owner/operator Exin Medical Technology Company, LLC
Owner/operator number 10059125
Product codes KGB
Device names KGB - Mask, Oxygen, Non-Rebreathing
Device class Class I
Classification regulations (21 CFR) 868.5570
Review panels Anesthesiology
Registered establishments EXIN MEDICAL TECHNOLOGY COMPANY, LLC
Establishment registrations 3015191173
FEI numbers 3015191173
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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