| Device Type ID | 2239 |
| Device Name | Warmer, Blood, Non-electromagnetic Radiation |
| 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 | BSB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2239 |
| Device | Warmer, Blood, Non-electromagnetic Radiation |
| Product Code | BSB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood And Plasma Warming Device. |
| CFR Regulation Number | 864.9205 [🔎] |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 46 |
Insufficient Information | 33 |
Fluid Leak | 14 |
Missing Value Reason | 7 |
Device Alarm System | 6 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Smoking | 3 |
Heater | 3 |
Crack | 2 |
Temperature Problem | 2 |
Alarm | 2 |
Insufficient Flow Or Under Infusion | 2 |
Motor | 2 |
Tube | 2 |
Pump | 2 |
Device Emits Odor | 2 |
Unknown (for Use When The Device Problem Is Not Known) | 2 |
Device Displays Incorrect Message | 2 |
Infusion Or Flow Problem | 2 |
Device Operational Issue | 1 |
Fail-Safe Problem | 1 |
Unit | 1 |
Switches | 1 |
No Apparent Adverse Event | 1 |
No Audible Alarm | 1 |
Inappropriate Audible Prompt / Feedback | 1 |
Protective Measures Problem | 1 |
Pumping Problem | 1 |
Air Leak | 1 |
Excess Flow Or Over-Infusion | 1 |
Accessory Incompatible | 1 |
Fail-Safe Design Failure | 1 |
Leak / Splash | 1 |
No Audible Prompt / Feedback | 1 |
Alarm, Audible | 1 |
Defective Alarm | 1 |
Thermal Decomposition Of Device | 1 |
Material Rupture | 1 |
Noise, Audible | 1 |
Thermistor | 1 |
Overheating Of Device | 1 |
Pumping Stopped | 1 |
| Total Device Problems | 161 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Estill Medical Technologies, Inc | II | Oct-21-2014 |