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Found 4 results
510(k) Data Aggregation
K Number
K130554Device Name
REDSENSE ALARM SYSTEM
Manufacturer
REDSENSE MEDICAL AB
Date Cleared
2013-11-22
(263 days)
Product Code
ODX
Regulation Number
876.5820Why did this record match?
Product Code :
ODX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment. The device includes a blood sensor incorporated into a sensor patch. The sensor monitors potential blood leakage from the venous needle blood access via a light signal and will alarm if blood leakage is detected by the device's sensor.
Device Description
Redsense Medical provides a system for monitoring the blood access during haemodialysis consisting of an alarm unit and a sensor connected to a specifically developed patch. The Redsense Patch uses integrated optic fibers to detect blood leakage from wounds. The optic fiber is connected to the sensor and alarm unit. If blood leakage occurs during haemodialysis, the patch surrounding the vein needle registers the event and changes a light signal to the alarm unit. This immediately activates a light and an alarm signal. Thus if a vein needle comes out of place extensive blood leakage is prevented.
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K Number
K103242Device Name
REDSENSE-ALARM UNIT AND SENSOR
Manufacturer
REDSENSE MEDICAL AB
Date Cleared
2011-02-10
(100 days)
Product Code
ODX
Regulation Number
876.5820Why did this record match?
Product Code :
ODX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing continuous hemodialysis treatment up to 8 hours in the clinical settings. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device's sensor patch.
Device Description
Redsense is a system for monitoring the vein needle during hemodialysis. Redsense consists of an alarm unit and optical sensor incorporated into an adhesive patch. The patch with the sensor is placed over the vein needle and detects any blood that drips onto the patch if the needle has been accidentally pulled out or if there is leakage during dialysis. If blood loss is detected, the device will alarm.
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K Number
K092955Device Name
REDSENSE-HOME USE
Manufacturer
REDSENSE MEDICAL AB
Date Cleared
2010-05-10
(227 days)
Product Code
ODX
Regulation Number
876.5820Why did this record match?
Product Code :
ODX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment up to 5 hours at home or in the clinical setting. The device includes a blood sensor incorporated into an adhesive dressing. The sensor monitors potential blood leakage from the needle puncture via an infrared light and will alarm if needle dislodgement or blood leakage is detected.
All use must be administrated under physician's prescription, and must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician.
Device Description
Redsense Home Use is a system for monitoring the vein or arterial needle during hemodialysis. Redsense consists of an alarm unit and optical sensor incorporated into an adhesive patch. The patch with the sensor is placed around the vein needle and detects any blood that drips onto the patch if the needle has been accidentally pulled out or if there is leakage during dialysis. If blood loss is detected, the device will alarm.
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K Number
K071013Device Name
REDSENSE
Manufacturer
REDSENSE MEDICAL AB
Date Cleared
2007-10-18
(191 days)
Product Code
ODX
Regulation Number
876.5820Why did this record match?
Product Code :
ODX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing continuous hemodialysis treatment up to 5 hours in the clinical setting. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device's sensor patch.
Device Description
Redsense is a system for monitoring the vein or arterial needle during hemodialysis. Redsense consists of an alarm unit and infrared sensor incorporated into an adhesive patch. The patch with the sensor is placed around the vein or arterial needle and detects any blood that drips onto the patch if the needle has been accidentally pulled out or if there is leakage during dialysis. If blood loss is detected, the device will alarm.
Ask a Question
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