FDA device listing

Anesthesia Circuit,Hudson Adult Rebreathing Circle Systems,Hudson Anesthesia Circuit,Hudson Anesthesia Circuit…

FDA device listing 1478543542 · Teleflex

Key facts

Proprietary names Anesthesia Circuit,Hudson Adult Rebreathing Circle Systems,Hudson Anesthesia Circuit,Hudson Anesthesia Circuit Accessories,Hudson CPRAM Anesthesia Circuits,Hudson Disposable Adult Rebreathing Circle Systems,Hudson Non-Rebreathing Single Limb Systems,Hudson Pediatric Rebreathing Circle Systems,Hudson RCI,Hudson RCI Conventional Breathing Circuits,Hudson Sampling lines and Filters,ISO-GARD Drain…
Owner/operator Teleflex
Owner/operator number 9062981
Product codes CAI
Device names CAI - Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device class Class I
Classification regulations (21 CFR) 868.5240
Review panels Anesthesiology
Registered establishments Teleflex Medical de Mexico, S. de R.L. de C.V., Teleflex Medical de Tecate, S. de R.L de C.V., Teleflex Medical LLC
Establishment registrations 3003898360, 3004365956, 3011137372
FEI numbers 3003898360, 3004365956, 3005747797
Establishment operations Complaint File Establishment, Specification Developer, 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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