| Device Type ID | 3366 |
| Device Name | System, Transport, Aerobic |
| Regulation Description | Microbiological Specimen Collection And Transport Device. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.2900 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JTW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 3366 |
| Device | System, Transport, Aerobic |
| Product Code | JTW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Microbiological Specimen Collection And Transport Device. |
| CFR Regulation Number | 866.2900 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 16 |
Device Contamination With Chemical Or Other Material | 5 |
Short Fill | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Volume Accuracy Problem | 2 |
Material Protrusion / Extrusion | 2 |
Delivered As Unsterile Product | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device Markings / Labelling Problem | 1 |
Incorrect Or Inadequate Test Results | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 37 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Becton Dickinson & Company | II | Nov-21-2018 |