| Device Type ID | 2795 |
| Device Name | Container, Specimen, Sterile |
| Regulation Description | Specimen Transport And Storage Container. |
| Regulation Medical Specialty | Pathology |
| 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 | 864.3250 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FMH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2795 |
| Device | Container, Specimen, Sterile |
| Product Code | FMH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Specimen Transport And Storage Container. |
| CFR Regulation Number | 864.3250 [🔎] |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 23 |
Leak / Splash | 20 |
Material Rupture | 12 |
Incorrect Or Inadequate Test Results | 9 |
Fluid Leak | 3 |
Device Operates Differently Than Expected | 3 |
Appropriate Term/Code Not Available | 3 |
Burst Container Or Vessel | 2 |
Defective Device | 2 |
Break | 2 |
Short Fill | 2 |
Difficult To Insert | 2 |
Material Deformation | 2 |
Material Separation | 1 |
Material Protrusion / Extrusion | 1 |
Failure To Disconnect | 1 |
Device Markings / Labelling Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Material Integrity Problem | 1 |
Incorrect Measurement | 1 |
Component Missing | 1 |
Activation, Positioning Or Separation Problem | 1 |
Difficult To Open Or Close | 1 |
Device Dislodged Or Dislocated | 1 |
Coagulation In Device Or Device Ingredient | 1 |
Unraveled Material | 1 |
| Total Device Problems | 99 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bard Medical Division | II | Aug-25-2018 |
| 2 | Covidien LLC | II | Dec-14-2016 |
| 3 | Customed, Inc | II | Sep-03-2015 |
| 4 | Customed, Inc | I | Dec-16-2014 |
| 5 | Customed, Inc | I | Aug-29-2014 |