← Product Code [MRH](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH) · K000420

# SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 (K000420)

_Retinalabs.Com · MRH · May 8, 2000 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K000420

## Device Facts

- **Applicant:** Retinalabs.Com
- **Product Code:** [MRH](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH.md)
- **Decision Date:** May 8, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5725
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K000420](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K000420)

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