đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Filtering solutions to remove particulate matter.
- Use as a filter unit in clinical or laboratory fluid-preparation settings, according to the device labeling.
Clinical Applications
- Filtering solutions during laboratory preparation.
- Filtering fluids before use in clinical or hospital workflows when particulate removal is required.
- Preparing solutions used in diagnostic or pharmaceutical settings, in accordance with the product labeling and institutional protocols.
Practical Considerations
- Confirm the membrane type, pore size, housing configuration, and fluid compatibility before use; the SLMP025SS and SLMPL25SS model designations should be matched to the manufacturer’s instructions.
- Use aseptic technique and inspect the package and filter for damage before use if sterility is required.
- Securely connect the filter to compatible tubing, syringes, or other equipment to prevent leakage, disconnection, or contamination.
- This is a single-use disposable filter; do not reuse it unless the current manufacturer labeling specifically permits reuse.
- MRI safety is not established from the available FDA record. Determine MRI compatibility from the current manufacturer’s labeling before bringing the device into an MRI environment.
Procedures that use this device
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.