Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.
| Device Type ID | 2517 |
| Device Name | Anesthesia Breathing Circuit Kit (adult & Pediatric) |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217. |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217. |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217. |
| Regulation Description | Anesthesia Breathing Circuit. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 868.5240 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OFP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2517 |
| Device | Anesthesia Breathing Circuit Kit (adult & Pediatric) |
| Product Code | OFP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Anesthesia Breathing Circuit. |
| CFR Regulation Number | 868.5240 [🔎] |
| Device Problems | |
|---|---|
Crack | 15 |
Cut In Material | 1 |
Blocked Connection | 1 |
Device Alarm System | 1 |
Hole In Material | 1 |
Material Integrity Problem | 1 |
Fracture | 1 |
Occlusion Within Device | 1 |
| Total Device Problems | 22 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Draeger Medical, Inc. | I | Jan-24-2019 |