Condenser, Heat And Moisture (artificial Nose)

Device Code: 46

Product Code(s): BYD

Device Type ID	46
Device Name	Condenser, Heat And Moisture (artificial Nose)
Regulation Description	Heat And Moisture Condenser (artificial Nose).
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) Exempt
CFR Regulation Number	868.5375 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	BYD
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	46
Device	Condenser, Heat And Moisture (artificial Nose)
Product Code	BYD
FDA Device Classification	Class 1 Medical Device
Regulation Description	Heat And Moisture Condenser (artificial Nose).
CFR Regulation Number	868.5375 [🔎]

Device Problems
Leak / Splash	19
Material Separation	15
Restricted Flow Rate	6
Fracture	6
Material Split, Cut Or Torn	4
Loose Or Intermittent Connection	4
Disconnection	4
Filter	2
Occlusion Within Device	2
Device Operates Differently Than Expected	2
Contamination / Decontamination Problem	1
Adverse Event Without Identified Device Or Use Problem	1
Suction Problem	1
Obstruction Of Flow	1
Structural Problem	1
Heat Exchanger	1
Crack	1
Split	1
Detachment Of Device Or Device Component	1
Insufficient Information	1
Moisture Or Humidity Problem	1
Material Fragmentation	1
Device Contamination With Chemical Or Other Material	1
Pressure Problem	1
Partial Blockage	1
Detachment Of Device Component	1
Total Device Problems	80

TPLC Last Update: 2019-04-02 19:27:22