21 CFR 880.5725 — Pump, Infusion
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5725
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FRN | Pump, Infusion | 2 | 848 | |
| LDR | Controller, Infusion, Intravascular, Electronic | 2 | 60 | |
| LGZ | Warmer, Thermal, Infusion Fluid | 2 | 75 | |
| LHF | Warmer, Microwave, Infusion Fluid | 2 | 2 | |
| LZF | Pump, Infusion, Analytical Sampling | 2 | 7 | |
| LZG | Pump, Infusion, Insulin | 2 | 84 | |
| LZH | Pump, Infusion, Enteral | 2 | 34 | |
| MEA | Pump, Infusion, Pca | 2 | 31 | |
| MEB | Pump, Infusion, Elastomeric | 2 | 88 | |
| MHD | Pump, Infusion, Gallstone Dissolution | 2 | 1 | |
| MRH | Pump, Infusion, Ophthalmic | 2 | 19 | |
| MRZ | Accessories, Pump, Infusion | 2 | 48 | |
| OPP | Pump, Infusion, Insulin Bolus | 2 | 7 | |
| PHC | Infusion Safety Management Software | 2 | 10 | SaMD |
| PKP | Immunoglobulin G (Igg) Infusion System | 2 | 7 | |
| PMS | Peripheral Intravenous (Piv) Infiltration Monitor | 2 | 5 | |
| QJY | Infusion Pump, Drug Specific, Pharmacy-Filled | 2 | 4 |
