Humidifier Nebulizer Kit

Device Code: 187

Product Code(s): OGG

Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Kit, As Described In The Guidance Above, Is Under Enforcemen

Device Classification Information

Device Type ID187
Device NameHumidifier Nebulizer Kit
Physical StateThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen
Technical MethodThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen
Target AreaThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen
Regulation DescriptionRespiratory Gas Humidifier.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission TypeEnforcement Discretion
CFR Regulation Number868.5450 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOGG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID187
DeviceHumidifier Nebulizer Kit
Product CodeOGG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionRespiratory Gas Humidifier.
CFR Regulation Number868.5450 [🔎]
Device Problems
Leak / Splash
101
Connection Problem
83
Device Operates Differently Than Expected
80
Failure To Deliver
60
Crack
24
Fitting Problem
21
Improper Flow Or Infusion
18
Break
16
No Flow
12
Melted
12
Overfill
11
Fluid Leak
7
Gas Leak
6
Disconnection
5
Air Leak
4
Inability To Auto-Fill
4
Hole In Material
3
Temperature Problem
3
Inaccurate Delivery
3
Insufficient Heating
3
Adverse Event Without Identified Device Or Use Problem
2
Restricted Flow Rate
2
Kinked
2
Insufficient Flow Or Under Infusion
2
Moisture Or Humidity Problem
2
Thermal Decomposition Of Device
1
Short Fill
1
Split
1
Insufficient Information
1
Noise, Audible
1
Mechanical Problem
1
Overheating Of Device
1
Filling Problem
1
Material Separation
1
Mechanical Jam
1
Failure To Infuse
1
Detachment Of Device Component
1
Difficult To Open Or Close
1
Appropriate Term/Code Not Available
1
Burst Container Or Vessel
1
False Alarm
1
Total Device Problems 502
Recalls
Manufacturer Recall Class Date Posted
1
Teleflex Medical
II Dec-12-2014
TPLC Last Update: 2019-04-02 19:30:20

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