FDA device listing

10mm Gas Sample Adaptor Kit (90006),15mm Gas Sample Adaptor Kit (90007),22mm Gas Sample Adaptor Kit (90017),Luer Elbow…

FDA device listing 1705073918 · Phillips-Medisize, LLC

Key facts

Proprietary names 10mm Gas Sample Adaptor Kit (90006),15mm Gas Sample Adaptor Kit (90007),22mm Gas Sample Adaptor Kit (90017),Luer Elbow 7.6mm Port Kit (90016)
Owner/operator Phillips-Medisize, LLC
Owner/operator number 2183833
Product codes BZA
Device names BZA - Connector, Airway (Extension)
Device class Class I
Classification regulations (21 CFR) 868.5810
Review panels Anesthesiology
Registered establishments MEDISIZE IRELAND LTD.
Establishment registrations 8020864
FEI numbers 3005737257
Establishment operations Contract 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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