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radiant medical endocatheter temperature probe
Radiant Medical
Summary: The Radiant Medical Endocatheter Temperature Probe is a device used to monitor and regulate body temperature in clinical settings. It is typically used by healthcare professionals in critical care and surgical environments.
FDA Clearance Information
Pathway
510K
Number
K042388 ↗
Decision Date
October 28, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Radiant Medical Endocatheter Temperature Probe was cleared through the FDA 510k pathway on October 28, 2004. Manufactured by Radiant Medical, it is classified as a Class 2 medical device.
What It Is
The Radiant Medical Endocatheter Temperature Probe is a specialized device designed to measure and control the temperature of patients undergoing medical procedures. It is inserted into the venous system, allowing for precise temperature monitoring and management. This device is particularly useful in maintaining normothermia during surgeries and in critical care settings.
Clinical Applications
Commonly used in operating rooms and intensive care units, the endocatheter temperature probe is vital for patients who require strict temperature management, such as those undergoing cardiac surgery or suffering from traumatic brain injuries. Anesthesiologists and critical care specialists frequently utilize this device to prevent hypothermia or hyperthermia, ensuring optimal patient outcomes.
Indications for Use
The FDA-cleared indications suggest this device is intended for patients who need continuous temperature monitoring and regulation, particularly during complex surgical procedures or in critical care scenarios. It is suitable for patients at risk of temperature instability.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and is compatible with standard monitoring systems. Proper insertion technique is crucial to ensure accurate readings and avoid complications. Clinicians should be familiar with the device's integration into existing patient monitoring setups.
Frequently Asked Questions
What is the Radiant Medical Endocatheter Temperature Probe used for?
It is used for continuous monitoring and regulation of body temperature in patients undergoing surgery or in critical care settings.
What specialties typically use this device?
Anesthesiology, critical care, and surgical specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring continuous temperature monitoring and management, especially during surgeries or in critical care.
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.