FDA device listing

AMBU,Aplicare,Berrcom,Best Health, Burnfree,Cambridge Sensors,Coflex Med,Curaplex,Curity,Dukal,Dynarex,First…

FDA device listing 1285834973 · NewView Oklahoma

Key facts

Proprietary names AMBU,Aplicare,Berrcom,Best Health, Burnfree,Cambridge Sensors,Coflex Med,Curaplex,Curity,Dukal,Dynarex,First Care,Flexpak,Genuine First Aid,Goodsense,Grafco,Honeywell,IvyX,Kerlix,McKesson,Medica,Medical Industries,Medi-First,Medline
Owner/operator NewView Oklahoma
Owner/operator number 10035470
Product codes LRR
Device names LRR - First Aid Kit With Drug
Device class Not classified
Classification regulations (21 CFR) ORCA1.LRR
Review panels General & Plastic Surgery
Registered establishments Newview Oklahoma, Inc
Establishment registrations 1644008
FEI numbers 1000117494
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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