Mouthpiece, Breathing

Device Code: 58

Product Code(s): BYP

Device Classification Information

• Device Type ID: 58
• Device Name: Mouthpiece, Breathing
• Regulation Description: Breathing Mouthpiece.
• 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: 868.5620 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: BYP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 1-134 ISO 18562-1 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 1: Evaluation And Testing Within A Risk Management Process
• 1-135 ISO 18562-2 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 2: Tests For Emissions Of Particulate Matter
• 1-136 ISO 18562-3 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 3: Tests For Emissions Of Volatile Organic Compounds
• 1-137 ISO 18562-4 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 4: Tests For Leachables In Condensate

Total Product Life Cycle

• Device Type ID: 58
• Device: Mouthpiece, Breathing
• Product Code: BYP
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Breathing Mouthpiece.
• CFR Regulation Number: 868.5620 [🔎]

Device Problems
Connection Error	1
Use Of Device Problem	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:27:36