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simplicity easy access ii infusion set for infusion and or injection of fluids into the body below the surface
Sterling Medivations
Summary: The Simplicity Easy Access II Infusion Set is a medical device used for the infusion and injection of fluids below the skin surface. It is primarily used by healthcare professionals in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K021005 ↗
Decision Date
April 25, 2002
Product Code
FPA
Device Class
Class 2
Evidence
0 studies
The Simplicity Easy Access II Infusion Set was cleared through the FDA 510(k) pathway on April 25, 2002. Manufactured by Sterling Medivations, it is classified as a Class 2 device under product code FPA.
What It Is
The Simplicity Easy Access II Infusion Set is designed for the infusion and injection of fluids into the body beneath the skin surface. It typically consists of a needle or cannula, tubing, and a connector for attaching to a fluid source. This device facilitates the administration of medications, nutrients, or other therapeutic fluids in a controlled manner, making it essential in various medical treatments.
Clinical Applications
This infusion set is commonly used in oncology for chemotherapy administration, in endocrinology for insulin delivery, and in general medicine for hydration and electrolyte balance. It is utilized in both inpatient and outpatient settings, catering to a wide range of patient populations from pediatrics to geriatrics. The device's design allows for ease of use in both hospital and home care environments.
Indications for Use
The FDA-cleared indications for this device include the infusion and injection of fluids into the body below the skin's surface. It is suitable for patients requiring regular fluid administration, such as those undergoing chemotherapy or receiving long-term medication.
Practical Considerations
The Simplicity Easy Access II Infusion Set comes in various sizes to accommodate different patient needs and anatomical sites. It is compatible with standard fluid administration systems. Clinicians should ensure proper technique to minimize the risk of infection and ensure effective fluid delivery.
Frequently Asked Questions
What is Simplicity Easy Access II Infusion Set used for?
It is used for the infusion and injection of fluids into the body below the skin's surface, commonly in chemotherapy, insulin delivery, and hydration therapy.
What specialties typically use this device?
Oncology, endocrinology, and general medicine are the primary specialties that utilize this device.
What are the FDA-cleared indications?
The device is indicated for the infusion and injection of fluids into the body below the skin's surface, suitable for patients needing regular fluid administration.
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.