MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER
Device Facts
| Record ID | K002409 |
|---|---|
| Device Name | MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER |
| Applicant | Automatic Medical Technologies, Inc. |
| Product Code | LGZ · General Hospital |
| Decision Date | Jun 28, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
