Product Classification

• Device: tube, tracheal/bronchial, differential ventilation (w/wo connector)
• Regulation Description: Tracheal/bronchial differential ventilation tube.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: CBI
• Premarket Review: Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C); Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
• Submission Type: 510(k)
• Regulation Number: 868.5740
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standards

• 1-62 ISO 5356-1 Third edition 2004-05-15
  Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
• 1-119 ISO 14408 Third edition 2016-02-15
  Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
• 1-127 ISO 16628 First edition 2008-11-15
  Tracheobronchial tubes-Sizing and marking
• 1-161 ISO 16628 Second edition 2022-06
  Anaesthetic and respiratory equipment - Tracheobronchial tubes
• 12-323 ISO 11990 Third edition 2018-08
  Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs

Third Party Review

Not Third Party Eligible