Changer, Tube, Endotracheal

Device Code: 144

Product Code(s): LNZ

Device Classification Information

• Device Type ID: 144
• Device Name: Changer, Tube, Endotracheal
• Regulation Description: Tracheal Tube.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Anesthesiology Devices Branch (ANDB)
• Submission Type: 510(k)
• CFR Regulation Number: 868.5730 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LNZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 12-247 ISO 11990-1 First Edition 2011-08-01
  Lasers And Laser-related Equipment - Determination Of Laser Resistance Of Tracheal Tubes - Part 1: Tracheal Tube Shaft
• 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

Total Product Life Cycle

• Device Type ID: 144
• Device: Changer, Tube, Endotracheal
• Product Code: LNZ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Tracheal Tube.
• CFR Regulation Number: 868.5730 [🔎]

Device Problems
Inflation Problem	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:29:39