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This document is a Special 510(k) submission outlining modifications to Hospira Infusion Sets, including safety and effectiveness information in compliance with FDA regulations.

How to fill out infusion set modification

How to fill out Infusion Set Modification

1. Gather the necessary information and documents required for the Infusion Set Modification.
2. Locate the appropriate forms or online portal for submitting the modification request.
3. Fill out the patient's personal information, including name, date of birth, and insurance details.
4. Specify the type of infusion set being modified and provide a reason for the modification.
5. Attach any supporting documents or medical records that justify the need for the modification.
6. Review the completed form for accuracy and completeness.
7. Submit the form via the designated method (online submission, mail, or fax).
8. Follow up with the healthcare provider or insurer to confirm receipt and processing of the modification request.

Who needs Infusion Set Modification?

1. Patients who require changes to their current infusion set due to medical reasons.
2. Individuals experiencing adverse reactions or complications with their current infusion set.
3. People who need a different type of infusion set for compatibility with new medications or treatment plans.
4. Patients in need of updated infusion sets that better suit their lifestyle or daily activities.

People Also Ask about

What is the use of infusion set in English?

The purpose of an infusion set is to deliver insulin under the skin, fulfilling a similar function like an intravenous line. It is a complete tubing system to connect an insulin pump to the pump user and as such includes a subcutaneous cannula, adhesive mount, quick-disconnect, and a pump cartridge connector.

What is a infusion device used for?

An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient's body in controlled amounts.

What is another name for an infusion set?

5:33 7:08 Clean your infusion site properly with an alcohol wipe or prep wipe. Allow your site to air dry.MoreClean your infusion site properly with an alcohol wipe or prep wipe. Allow your site to air dry.

How to change infusion set?

The infusion set must be replaced and rotated every 2-3 days. Establish a rotation schedule that best fits your needs. With experience, you will find areas that not only provide better absorption, but are more comfortable.

What is the purpose of the infusion set?

An IV set, or intravenous set, is a medical device used to deliver fluids, medications, and nutrients directly into a patient's vein. It consists of several components that work together to ensure a controlled and precise flow of fluids.

How long can an infusion set be used?

Standard insulin infusion sets (IISs) are to be replaced every 2 to 3 days to avoid complications and diabetic ketosis due to set failure. This pivotal trial evaluated the safety and performance of a new extended-wear infusion set (EIS) when used for 7 days by adults with type 1 diabetes (T1D).

What is the purpose of an infusion?

Infusion therapy, or intravenous therapy, is one way to treat or manage neurological conditions or disorders of the nervous system. Infusion therapy involves administering medication directly into the bloodstream to change or alter the immune system, said Todd Levine, MD, a neurologist at HonorHealth Neurology. Dr.

For pdfFiller’s FAQs

What is Infusion Set Modification?

Infusion Set Modification refers to the process of making changes or updates to the design, function, or materials used in an infusion set, which is a device that delivers medications directly into the bloodstream.

Who is required to file Infusion Set Modification?

The manufacturer of the infusion set or the entity responsible for its modifications is typically required to file for Infusion Set Modification with the appropriate regulatory bodies.

How to fill out Infusion Set Modification?

To fill out an Infusion Set Modification, one must complete the specific application form provided by the regulatory authority, providing detailed information about the modifications made, including their rationale and the expected impact on safety and efficacy.

What is the purpose of Infusion Set Modification?

The purpose of Infusion Set Modification is to ensure that any changes made to the device are thoroughly evaluated for safety, effectiveness, and compliance with regulatory standards, thereby protecting patient health.

What information must be reported on Infusion Set Modification?

The information that must be reported includes details about the original infusion set, a description of the modifications, intended use, testing data, and any potential effects on device performance.