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 Type ID | 187 |
| Device Name | Humidifier Nebulizer Kit |
| Physical State | 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 |
| Technical Method | 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 |
| Target Area | 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 |
| Regulation Description | Respiratory Gas Humidifier. |
| 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 | Enforcement Discretion |
| CFR Regulation Number | 868.5450 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OGG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 187 |
| Device | Humidifier Nebulizer Kit |
| Product Code | OGG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Respiratory Gas Humidifier. |
| CFR Regulation Number | 868.5450 [🔎] |
| 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 |