| Device Type ID | 2532 |
| Device Name | Tube, Aspirating, Flexible, Connecting |
| Regulation Description | Vacuum-powered Body Fluid Suction Apparatus. |
| Regulation Medical Specialty | General Hospital |
| 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 | 510(K) Exempt |
| CFR Regulation Number | 880.6740 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BYY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2532 |
| Device | Tube, Aspirating, Flexible, Connecting |
| Product Code | BYY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vacuum-powered Body Fluid Suction Apparatus. |
| CFR Regulation Number | 880.6740 [🔎] |
| Device Problems | |
|---|---|
Packaging Problem | 15 |
Unsealed Device Packaging | 13 |
Device Packaging Compromised | 9 |
Delivered As Unsterile Product | 8 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Material Twisted / Bent | 1 |
| Total Device Problems | 47 |