| Device Type ID | 2609 |
| Device Name | Tubing, Noninvasive |
| 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 | GAZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2609 |
| Device | Tubing, Noninvasive |
| Product Code | GAZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vacuum-powered Body Fluid Suction Apparatus. |
| CFR Regulation Number | 880.6740 [🔎] |
| Device Problems | |
|---|---|
Defective Device | 4 |
Detachment Of Device Or Device Component | 3 |
Detachment Of Device Component | 2 |
Material Integrity Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Use Of Device Problem | 1 |
Leak / Splash | 1 |
Hole In Material | 1 |
Off-Label Use | 1 |
Human Factors Issue | 1 |
Device Handling Problem | 1 |
Collapse | 1 |
Fluid Leak | 1 |
Decrease In Suction | 1 |
Disconnection | 1 |
| Total Device Problems | 22 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ConMed Corporation | II | Oct-18-2016 |
| 2 | Medtronic Minimally Invasive Therapies Group | II | Mar-05-2018 |