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510(k) Data Aggregation
K Number
K151040Device Name
Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
Manufacturer
BIOMETRIX LTD.
Date Cleared
2015-09-04
(137 days)
Product Code
DRS
Regulation Number
870.2850Why did this record match?
Applicant Name (Manufacturer) :
BIOMETRIX LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Art-Line™ Disposable Pressure Transducer Set (Art-Line™ DPT) is intended for measuring of the blood and/or intra-abdominal pressure of the critically ill patients.
The blood pressure sensing is carried out by converting of the hemodynamic waves from a patient's intravasular catheter, through the integrated pressure transducer/sensor, into electrical signals which can be displayed on a monitoring equipment. The intra-abdominal pressure sensing is carried out in the same manner, however by converting of the physiological waves from the patient's inflated bladder.
The device is for single and short term use.
Device Description
The Art-Line™ Disposable Pressure Transducer (Art-Line™ DPT ) set is a disposable pressure transducer device that interfaces between a catheter and a monitoring equipment by converting changes in pressure into electrical signals. The Art-Line™ DPT (see Table 1.) is offered in different configurations to fit physicians' needs: with one, two or three channel lines. Also it may be offered as a closed system which assist to prevent blood loss and minimize a cross contamination risk. The complete configuration may be pole or patient mounted. The set is sterile and non-pyrogenic.
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K Number
K011216Device Name
PVC FREE INTRAVASCULAR ADMINISTRATION SET
Manufacturer
BIOMETRIX LTD.
Date Cleared
2001-07-18
(89 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BIOMETRIX LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001461Device Name
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
Manufacturer
BIOMETRIX LTD.
Date Cleared
2000-09-11
(124 days)
Product Code
KPE
Regulation Number
880.5025Why did this record match?
Applicant Name (Manufacturer) :
BIOMETRIX LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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