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This document provides a summary of the safety and effectiveness of the LIFESHIELD™ VISION™ Infusion Sets with pre-pierced reseal modification, in accordance with 510(k) requirements.
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How to fill out lifeshield vision pre-pierced reseal
How to fill out LIFESHIELD™ VISION™ Pre-Pierced Reseal Modification
01
Begin by cleaning the work area to ensure a sterile environment.
02
Gather all necessary materials, including the LIFESHIELD™ VISION™ system and the pre-pierced reseal modification kit.
03
Open the modification kit and inspect the contents for any damage.
04
Follow the instructions in the kit to prepare the modification for application.
05
Align the pre-pierced reseal modification with the designated area on the LIFESHIELD™ VISION™ device.
06
Secure the modification in place, ensuring it fits snugly and is properly sealed.
07
Perform a final inspection to confirm that the reseal modification is correctly applied.
08
Dispose of any used materials according to safety guidelines.
Who needs LIFESHIELD™ VISION™ Pre-Pierced Reseal Modification?
01
Individuals or healthcare facilities that use LIFESHIELD™ VISION™ devices and need to modify them for specific applications or improvements.
02
Users seeking enhanced performance or additional features in their pre-pierced devices.
03
Patients requiring customized adjustments to meet their medical or lifestyle needs.
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What is LIFESHIELD™ VISION™ Pre-Pierced Reseal Modification?
LIFESHIELD™ VISION™ Pre-Pierced Reseal Modification is a procedure designed to enhance the integrity and safety of certain medical devices by ensuring they are properly resealed after being pre-pierced, allowing for efficient usage while preventing contamination.
Who is required to file LIFESHIELD™ VISION™ Pre-Pierced Reseal Modification?
Manufacturers and distributors of medical devices that utilize the LIFESHIELD™ VISION™ technology are required to file this modification to ensure compliance with regulatory standards.
How to fill out LIFESHIELD™ VISION™ Pre-Pierced Reseal Modification?
To fill out the modification, the submitter should complete the designated form by providing necessary details such as device identification, the purpose of the modification, and any relevant testing or validation data.
What is the purpose of LIFESHIELD™ VISION™ Pre-Pierced Reseal Modification?
The primary purpose of this modification is to ensure the safety, performance, and regulatory compliance of medical devices that have undergone pre-piercing, allowing them to be resealed properly for safe use.
What information must be reported on LIFESHIELD™ VISION™ Pre-Pierced Reseal Modification?
The report must include detailed information such as the device's name, model number, pre-piercing method used, testing results, and any potential impacts on device performance or safety.
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