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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 510K
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.
Clinical Applications
This device is commonly used in hospital and laboratory settings where sterile filtration of fluids is required. It is particularly useful in pharmacy departments, during the preparation of intravenous medications, and in research labs. The device is suitable for use with a wide range of fluids, making it versatile for different specialties including oncology, infectious diseases, and surgery.
Indications for Use
The FDA-cleared indications for the Millex GP Sterilizing Filter Unit involve its use in sterilizing fluids to prevent contamination. It is intended for use in situations where maintaining sterility is critical, such as in the preparation of intravenous solutions or other sterile fluids.
Practical Considerations
The Millex GP Sterilizing Filter Unit is available in various sizes to accommodate different volumes of fluid. It is compatible with standard laboratory and clinical equipment, making it easy to integrate into existing workflows. Proper technique in handling and installation is essential to ensure optimal performance and sterility.
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.