FDA device listing

BODAI NEO2-SAFE

FDA device listing 1141721755 · B&B MEDICAL TECHNOLOGIES, INC.

Key facts

Proprietary names BODAI NEO2-SAFE
Owner/operator B&B MEDICAL TECHNOLOGIES, INC.
Owner/operator number 9089880
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 B & B MEDICAL TECHNOLOGIES, INC.
Establishment registrations 2938401
FEI numbers 2938401
Establishment operations Specification Developer
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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