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510(k) Data Aggregation
K Number
K152472Device Name
Disposable Pressure Transducer
Manufacturer
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
Date Cleared
2016-10-31
(427 days)
Product Code
DRS
Regulation Number
870.2850Why did this record match?
Applicant Name (Manufacturer) :
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Blood Pressure Transducer (DBPT) is intended for direct measurement and monitoring of fluid pressure.
Device Description
The Disposable Blood Pressure Transducer (DBPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the DBPT include the DBPT module that houses a ceramic, a luer connector with locking collar that can connect to an intravascular catheter, a transducer cable that can connect to a compatible pressure monitor and a stopcock for altering direction of fluid flow. The DBPT is provided sterile and for single use.
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K Number
K151498Device Name
Breathing circuit bacterial/viral filter
Manufacturer
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
Date Cleared
2015-12-18
(197 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to add, maintain, retain moisture for the exhaled breathe of the patient. Use up to 24 hours.
The Models of the filters are A501-1, A501-2, A501-3, and A501-4. The filters are intended for patient population that weighs greater than 10Kgs.
Device Description
Breathing circuit bacterial/viral filter has into two models: - 1) Bacterial/ viral filters; 2) Bacterial/viral filters HME. Breathing circuit bacterial/viral filters are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15/22 mm connectors with a gas sampling luer port. The depth filter use electrostatic media for filtration and a foam media for the HME media.
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