FDA device listing

Heated Breathing Set

FDA device listing 2015405009 · Telesair, Inc.

Key facts

Proprietary names Heated Breathing Set
Owner/operator Telesair, Inc.
Owner/operator number 10084443
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 Telesair, Inc.
Establishment registrations 3021947238
FEI numbers 3021947238
Establishment operations 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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