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millex - mp filter unit slmpo25ss slmpl25ss
Millipore
Summary: The Millex - MP Filter Unit is a medical device used primarily for filtering solutions in clinical settings. It is typically utilized by healthcare professionals in laboratories and hospitals.
FDA Clearance Information
Pathway 510K
Number K963717 ↗
Decision Date June 10, 1997
Product Code BSN
Device Class Class 2
Evidence 0 studies
The Millex - MP Filter Unit, manufactured by Millipore, was cleared through the FDA 510(k) pathway on June 10, 1997. It is classified as a Class 2 device under product code BSN.
What It Is
The Millex - MP Filter Unit is a sterile, disposable filter designed to remove particulates from solutions. It is commonly used in laboratory and clinical settings to ensure the purity of fluids before they are administered to patients or used in diagnostic procedures. The device operates by passing the solution through a membrane filter, capturing unwanted particles.
Clinical Applications
This filter unit is frequently used in clinical laboratories and hospital settings for the preparation of intravenous solutions and other sterile fluids. It is particularly useful in situations where fluid purity is critical, such as in the preparation of medications for immunocompromised patients. The device is utilized by healthcare professionals in specialties such as pharmacy, oncology, and infectious disease.
Indications for Use
The FDA-cleared indications for the Millex - MP Filter Unit involve its use in filtering solutions to remove particulates. It is intended for use in clinical settings where sterile fluid preparation is necessary, particularly for patients requiring high-purity solutions.
Practical Considerations
The Millex - MP Filter Unit is available in various pore sizes to accommodate different filtration needs. It is compatible with standard laboratory and clinical equipment, making it versatile for various applications. Proper technique involves ensuring the filter is securely attached to the fluid source to prevent leaks.
Frequently Asked Questions
What is Millex - MP Filter Unit used for?
It is used for filtering solutions to remove particulates, ensuring fluid purity in clinical settings.
What specialties typically use this device?
Specialties such as pharmacy, oncology, and infectious disease commonly use this device.
What are the FDA-cleared indications?
The device is indicated for filtering solutions to remove particulates, ensuring sterile fluid preparation.
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.