DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
Device Facts
| Record ID | K001629 |
|---|---|
| Device Name | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM |
| Applicant | Disetronic Medical Systems AG |
| Product Code | FRN · General Hospital |
| Decision Date | Jun 21, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.
