đź“‹ FDA Reference
Millex Gp Sterilizing Filter Unit Model Slgp 033 R
Millipore
Summary: The Millex GP Sterilizing Filter Unit is a medical device used for sterilizing fluids in clinical settings. It is typically used by healthcare professionals in various specialties to ensure the sterility of solutions before administration to patients.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K013988 ↗
Decision Date ?
April 4, 2002
Product Code ?
BSN
Device Class ?
Class 2
Evidence ?
0 studies
The Millex GP Sterilizing Filter Unit, manufactured by Millipore, was cleared by the FDA via the 510k pathway on April 4, 2002. It is classified as a Class 2 device under product code BSN.
What It Is
The Millex GP Sterilizing Filter Unit is designed to sterilize fluids by removing bacteria and particulates. It operates by passing fluids through a membrane filter, ensuring that the output is free from contaminants. This device is crucial in maintaining sterility in clinical environments, particularly when preparing intravenous solutions or other sterile fluids.
FDA-Cleared Indications
- Sterilization of fluids by filtration to remove bacteria and particulates.
- Use when sterile filtration of a fluid is required before clinical or laboratory use.
Clinical Applications
- Sterile preparation of intravenous solutions and medications.
- Filtration of fluids in hospital pharmacy workflows.
- Sterile fluid preparation in clinical laboratories.
- Sterile filtration of research or laboratory solutions when compatible with the device.
Practical Considerations
- Select the filter configuration and size appropriate for the fluid volume, flow requirements, and compatible equipment.
- Use aseptic handling, proper installation, and appropriate connections to preserve sterility.
- Verify chemical compatibility between the fluid and the filter membrane before use.
- This is a fluid-filtration device, not an implantable device; MRI safety considerations generally do not apply, but any connected equipment should be assessed separately.
- Follow the current manufacturer instructions for use, including single-use, storage, priming, pressure, and disposal requirements.
Frequently Asked Questions
What is the Millex GP Sterilizing Filter Unit used for?
It is used for sterilizing fluids by removing bacteria and particulates, ensuring the sterility of solutions before administration.
What specialties typically use this device?
Specialties such as pharmacy, oncology, infectious diseases, and surgery commonly use this device in hospital and laboratory settings.
What are the FDA-cleared indications?
The device is indicated for sterilizing fluids to prevent contamination, particularly in the preparation of intravenous solutions or other sterile fluids.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.