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510(k) Data Aggregation
K Number
K071269Device Name
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
Manufacturer
SMITHS MEDICAL ASD, INC.
Date Cleared
2007-08-01
(86 days)
Product Code
CBT
Regulation Number
868.1100Why did this record match?
Product Code :
CBT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemoDraw™ Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.
Device Description
Not Found
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K Number
K070340Device Name
SECURE ARTERIAL BLOOD SAMPLING SYSTEM
Manufacturer
SMITHS MEDICAL ASD, INC.
Date Cleared
2007-03-15
(37 days)
Product Code
CBT
Regulation Number
868.1100Why did this record match?
Product Code :
CBT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.
Device Description
The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system.
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K Number
K955663Device Name
ABC IN-LINE BLOOD SAMPLING KIT
Manufacturer
UTAH MEDICAL PRODUCTS, INC.
Date Cleared
1997-03-17
(460 days)
Product Code
CBT
Regulation Number
868.1100Why did this record match?
Product Code :
CBT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ABC ("Arterial Blood Collection") In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.
Device Description
The ABC ("Arterial Blood Collection") In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.
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