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cd home dialyservice hemodialysis tray
Cd Medical
Summary: The CD Home Dialyservice Hemodialysis Tray is a medical device used for home hemodialysis procedures. It is designed for patients requiring dialysis treatment outside of clinical settings, typically managed by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway
510K
Number
K925654 ↗
Decision Date
March 30, 1994
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The CD Home Dialyservice Hemodialysis Tray was cleared through the FDA 510(k) pathway on March 30, 1994. Manufactured by Cd Medical, it is classified as a Class 2 device under product code KOC.
What It Is
This device is a hemodialysis tray designed for home use, facilitating the dialysis process by organizing and providing necessary components for the procedure. It typically includes items such as tubing, needles, and other accessories needed to perform hemodialysis safely and effectively in a non-clinical setting. The tray helps streamline the setup and execution of dialysis, ensuring that patients or caregivers can manage the treatment with ease.
Clinical Applications
The CD Home Dialyservice Hemodialysis Tray is commonly used in home healthcare settings for patients with chronic kidney disease requiring regular dialysis. It is particularly beneficial for patients who prefer or require dialysis outside of a traditional clinic, such as those with mobility issues or those living in remote areas. Nephrologists, dialysis nurses, and trained caregivers are typically involved in the setup and monitoring of home dialysis using this device.
Indications for Use
The device is intended for patients who need hemodialysis as part of their treatment for kidney failure. It is suitable for individuals who have been trained to perform dialysis at home or have a caregiver who can assist with the procedure.
Practical Considerations
When using the CD Home Dialyservice Hemodialysis Tray, it is important to ensure compatibility with the patient's dialysis machine and access type. The tray components should be checked for sterility and integrity before use. Proper training in home dialysis techniques is essential to ensure patient safety and treatment efficacy.
Frequently Asked Questions
What is CD Home Dialyservice Hemodialysis Tray used for?
It is used for performing hemodialysis at home, allowing patients with kidney failure to receive treatment outside of a clinical setting.
What specialties typically use this device?
Nephrology and home healthcare professionals, including dialysis nurses and trained caregivers, typically use this device.
What are the FDA-cleared indications?
The device is indicated for home hemodialysis in patients with chronic kidney disease who require regular dialysis treatment.
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.