Mixer, Breathing Gases, Anesthesia Inhalation

Device Code: 76

Product Code(s): BZR

Device Classification Information

• Device Type ID: 76
• Device Name: Mixer, Breathing Gases, Anesthesia Inhalation
• Regulation Description: Breathing Gas Mixer.
• 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: 868.5330 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: BZR
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

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: 76
• Device: Mixer, Breathing Gases, Anesthesia Inhalation
• Product Code: BZR
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Breathing Gas Mixer.
• CFR Regulation Number: 868.5330 [🔎]

Premarket Reviews
Manufacturer	Decision
GENTEC (SHANGHAI) CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MAXTEC, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Inaccurate Delivery	23
Device Operates Differently Than Expected	12
No Audible Alarm	9
Device Alarm System	7
Out-Of-Box Failure	6
Output Problem	2
Failure To Calibrate	2
False Alarm	2
Device Sensing Problem	1
Fire	1
Therapeutic Or Diagnostic Output Failure	1
High Readings	1
Mechanical Problem	1
Calibration Problem	1
Defective Alarm	1
Misassembly During Maintenance / Repair	1
Leak / Splash	1
Total Device Problems	72

Recalls
Manufacturer		Recall Class	Date Posted
1	CAREstream Medical LLC	II	Aug-22-2018
2	O-Two Medical Technologies, Inc.	II	Aug-22-2018

TPLC Last Update: 2019-04-02 19:27:55