Definition: To Perform Non-bronchoscopic Bronchoalveolar Lavage (bal) In Adult Patients Undergoing Mechanical Ventilation.
| Device Type ID | 196 |
| Device Name | Non-bronchoscopic Bronchoalveolar Lavage Catheter |
| Physical State | This Device Is A Catheter |
| Technical Method | The Device Is Inserted Into A Patient's Lungs To Collect Bronchoalveolar Labage Specimens |
| Target Area | Lungs |
| Regulation Description | Tracheobronchial Suction Catheter. |
| 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 | 868.6810 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OYI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 196 |
| Device | Non-bronchoscopic Bronchoalveolar Lavage Catheter |
| Product Code | OYI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Tracheobronchial Suction Catheter. |
| CFR Regulation Number | 868.6810 [🔎] |