đź“‹ FDA Reference
epidural minifilter luer 80369-7 epidural minifilter nrfit 80369-6
Pajunk Gmbh Medizintechnologie
Summary: The Epidural Minifilter Luer and NRFit are medical devices used for filtering medications in epidural procedures. They are typically utilized by anesthesiologists and pain management specialists.
FDA Clearance Information
Pathway
510K
Number
K190663 ↗
Decision Date
June 17, 2019
Product Code
BSN
Device Class
Class 2
Evidence
0 studies
The Epidural Minifilter, manufactured by Pajunk Gmbh Medizintechnologie, received FDA clearance through the 510k pathway on June 17, 2019. It is classified as a Class 2 device under product code BSN.
What It Is
The Epidural Minifilter is a specialized filter designed for use in epidural procedures to ensure the purity of medications administered. It connects to epidural catheters via Luer or NRFit connectors, which are standardized to prevent misconnections. The device helps reduce the risk of particulate contamination during drug delivery in epidural spaces.
Clinical Applications
This device is commonly used in anesthesiology, particularly during labor and delivery, as well as in chronic pain management procedures. It is suitable for use in hospital settings where epidural analgesia or anesthesia is administered. The device is beneficial for patients requiring long-term epidural infusions, ensuring medication safety and efficacy.
Indications for Use
The Epidural Minifilter is indicated for use in filtering medications administered through epidural catheters. It is particularly useful for patients undergoing epidural anesthesia or analgesia, ensuring that the medication delivered is free from particulates.
Practical Considerations
The device is available in configurations compatible with both Luer and NRFit connectors, aligning with international standards to prevent misconnections. Clinicians should ensure compatibility with existing epidural systems and be familiar with the connection techniques to optimize safety and efficacy.
Frequently Asked Questions
What is the Epidural Minifilter used for?
It is used to filter medications administered through epidural catheters to ensure they are free from particulates.
What specialties typically use this device?
Anesthesiologists and pain management specialists commonly use this device during epidural procedures.
What are the FDA-cleared indications?
The device is indicated for filtering medications in epidural anesthesia or analgesia procedures to ensure purity and safety.
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.