| Device Type ID | 119 |
| Device Name | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Regulation Description | Medicinal Nonventilatory Nebulizer (atomizer). |
| 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 | 868.5640 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CCQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 119 |
| Device | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Product Code | CCQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Medicinal Nonventilatory Nebulizer (atomizer). |
| CFR Regulation Number | 868.5640 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 48 |
Detachment Of Device Component | 46 |
No Flow | 32 |
Break | 30 |
Device Operates Differently Than Expected | 21 |
Detachment Of Device Or Device Component | 20 |
Failure To Deliver | 18 |
Failure To Fire | 12 |
Device Damaged Prior To Use | 12 |
Packaging Problem | 10 |
Tear, Rip Or Hole In Device Packaging | 9 |
Restricted Flow Rate | 8 |
Complete Blockage | 6 |
Loss Of Or Failure To Bond | 6 |
Connection Problem | 6 |
Inaccurate Delivery | 4 |
Disconnection | 3 |
Unsealed Device Packaging | 3 |
Partial Blockage | 3 |
Device Handling Problem | 2 |
Insufficient Information | 2 |
Obstruction Of Flow | 2 |
Component Missing | 2 |
Activation, Positioning Or Separation Problem | 1 |
Use Of Device Problem | 1 |
Device Difficult To Maintain | 1 |
Occlusion Within Device | 1 |
Battery Problem | 1 |
Improper Flow Or Infusion | 1 |
Failure To Convert To Back-Up | 1 |
Kinked | 1 |
Device Markings / Labelling Problem | 1 |
Moisture Or Humidity Problem | 1 |
Positioning Problem | 1 |
Air Leak | 1 |
| Total Device Problems | 317 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Teleflex Medical | II | Nov-09-2016 |