| Device Type ID | 2409 |
| Device Name | Device, Warming. Blood And Plasma |
| Regulation Description | Blood And Plasma Warming Device. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9205 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KZL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2409 |
| Device | Device, Warming. Blood And Plasma |
| Product Code | KZL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood And Plasma Warming Device. |
| CFR Regulation Number | 864.9205 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BELMONT INSTRUMENT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Rupture | 6 |
Tube | 4 |
Leak / Splash | 3 |
Fitting Problem | 2 |
Detachment Of Device Component | 2 |
Cassette | 2 |
Kinked | 2 |
Insufficient Flow Or Under Infusion | 1 |
Break | 1 |
Insufficient Information | 1 |
Air Leak | 1 |
Out-Of-Box Failure | 1 |
System | 1 |
Physical Resistance | 1 |
Device Operates Differently Than Expected | 1 |
Infusion Or Flow Problem | 1 |
Device Component Or Accessory | 1 |
Device Difficult To Setup Or Prepare | 1 |
Deformation Due To Compressive Stress | 1 |
| Total Device Problems | 33 |