| Device Type ID | 2403 |
| Device Name | Supplies, Blood-bank |
| Regulation Description | Blood Bank Supplies. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9050 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KSS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2403 |
| Device | Supplies, Blood-bank |
| Product Code | KSS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Blood Bank Supplies. |
| CFR Regulation Number | 864.9050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MACOPRODUCTIONS S.A.S. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TYPENEX MEDICAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Difficult To Setup Or Prepare | 6 |
Insufficient Information | 4 |
Leak / Splash | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Pressure Problem | 1 |
Crack | 1 |
Fluid Leak | 1 |
Particulates | 1 |
Delivered As Unsterile Product | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Contamination With Body Fluid | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Fracture | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 24 |