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 Type Of Convenience Kit, As Listed In The Guidance Above, Is
| Device Type ID | 724 |
| Device Name | Cardiopulmonary Resuscitation Aid 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 Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| 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 Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| 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 Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Regulation Description | Manual Emergency Ventilator. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 868.5915 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OEV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 724 |
| Device | Cardiopulmonary Resuscitation Aid Kit |
| Product Code | OEV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Manual Emergency Ventilator. |
| CFR Regulation Number | 868.5915 [🔎] |
| Device Problems | |
|---|---|
Disconnection | 2 |
Failure To Disconnect | 2 |
Mechanical Problem | 2 |
Blocked Connection | 1 |
Detachment Of Device Or Device Component | 1 |
Pressure Problem | 1 |
Air Leak | 1 |
Device Operates Differently Than Expected | 1 |
Infusion Or Flow Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 13 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Vyaire Medical | I | May-10-2018 |