| Device Type ID | 2402 |
| Device Name | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Regulation Description | Empty Container For The Collection And Processing Of Blood And Blood Components. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KSR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2402 |
| Device | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Product Code | KSR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Empty Container For The Collection And Processing Of Blood And Blood Components. |
| CFR Regulation Number | 864.9100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FRESENIUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FRESENIUS KABI AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORIGEN BIOMEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PALL EUROPE LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Crack | 2 |
Component Missing | 2 |
Use Of Device Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Failure To Adhere Or Bond | 1 |
Defective Component | 1 |
Insufficient Information | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Scratched Material | 1 |
Material Deformation | 1 |
| Total Device Problems | 12 |