Brush, Cleaning, Tracheal Tube

Device Code: 124

Product Code(s): EPE

Device Classification Information

• Device Type ID: 124
• Device Name: Brush, Cleaning, Tracheal Tube
• Regulation Description: Tracheal Tube Cleaning Brush.
• 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); Respiratory Devices Branch (RPDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 868.5795 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: EPE
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 124
• Device: Brush, Cleaning, Tracheal Tube
• Product Code: EPE
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Tracheal Tube Cleaning Brush.
• CFR Regulation Number: 868.5795 [🔎]

Device Problems
Insufficient Information	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:29:23