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510(k) Data Aggregation
K Number
K240164Device Name
NovaLine SP-C35 Transducer Protector (956007)
Manufacturer
Bain Medical Equipment (Guangzhou) Co., Ltd.
Date Cleared
2024-06-28
(158 days)
Product Code
FIB
Regulation Number
876.5820Why did this record match?
Product Code :
FIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NovaLine SP-C35 Transducer Protector is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.
Device Description
The NovaLine SP-C35 Transducer Protector consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.2 µ m. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine.
The NovaLine SP-C35 Transducer Protector is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 ↓ m hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor.
The devices are packaged sterile and labeled for single use only.
The proposed devices are provided in sterile condition, it is subject to e-beam radiation sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.
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K Number
K072988Device Name
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
Manufacturer
NIPRO MEDICAL CORPORATION
Date Cleared
2008-02-21
(121 days)
Product Code
FIB
Regulation Number
876.5820Why did this record match?
Product Code :
FIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nipro Transducer Protector TP-SURE is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.
Device Description
The Nipro Transducer Protector TP-SURE consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.1 um. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine.
The TP-SURE is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.1 µm hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor.
The devices are packaged sterile and labeled for single use only. There is no ability to clean and reuse these devices. They are restricted for sale by or on the order of a physician.
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K Number
K001971Device Name
HEMODIALYSIS TUBING SETS
Manufacturer
OFI BIOMEDICA S.P.A.
Date Cleared
2001-05-24
(330 days)
Product Code
FIB
Regulation Number
876.5820Why did this record match?
Product Code :
FIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010264Device Name
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
Manufacturer
NIPRO MEDICAL CORP.
Date Cleared
2001-04-27
(88 days)
Product Code
FIB
Regulation Number
876.5820Why did this record match?
Product Code :
FIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001465Device Name
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
Manufacturer
NIPRO MEDICAL CORP.
Date Cleared
2000-12-05
(209 days)
Product Code
FIB
Regulation Number
876.5820Why did this record match?
Product Code :
FIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003445Device Name
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
Manufacturer
FRESENIUS MEDICAL CARE NORTH AMERICA
Date Cleared
2000-12-01
(25 days)
Product Code
FIB
Regulation Number
876.5820Why did this record match?
Product Code :
FIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000702Device Name
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
Manufacturer
FRESENIUS MEDICAL CARE NORTH AMERICA
Date Cleared
2000-06-07
(98 days)
Product Code
FIB
Regulation Number
876.5820Why did this record match?
Product Code :
FIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983076Device Name
MEDISYSTEMS TRANSDUCER PROTECTOR
Manufacturer
MEDISYSTEMS CORP.
Date Cleared
1998-11-25
(84 days)
Product Code
FIB
Regulation Number
876.5820Why did this record match?
Product Code :
FIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medisystems Transducer Protectors are indicated for use as protective devices for pressure monitors on hemodialysis machines as well as to help protect the sterility of the blood tubing fluid pathway. The filter helps prevent cross-contamination by viruses, bacteria, and other particulate matter while preventing the flow of fluids to the hemodialysis machine's pressure transducer.
Device Description
Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 um hydrophobic filter helps prevent cross-contamination by viruses, bacteria and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor. The technical characteristics of the device consist of a filter housing that contains a 0.2 um hydrophobic filter. The combination of the pore size and hydrophobic nature of the filter also prevents the flow of fluids, viruses, bacteria, and particulate matter into the pressure monitor at pressures lower than the rated pressure of the device.
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K Number
K964337Device Name
BETTER-BLADDER (BB)
Manufacturer
CIRCULATORY TECHNOLOGY, INC.
Date Cleared
1997-05-23
(204 days)
Product Code
FIB
Regulation Number
876.5820Why did this record match?
Product Code :
FIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made. The noninvasive pressure obtained. with the BB can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during routine bypass procedures.
Device Description
The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made. The noninvasive pressure obtained. with the BB can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during routine bypass procedures.
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K Number
K970536Device Name
MEDISYSTEMS TRANDUCER PROTECTOR
Manufacturer
MEDISYSTEMS CORP.
Date Cleared
1997-05-12
(89 days)
Product Code
FIB
Regulation Number
876.5820Why did this record match?
Product Code :
FIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medisystems Transducer Protectors are single use, disposable prescription devices intended for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway.
Device Description
Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 µm hydrophobic filter helps prevent cross-contamination by bacteria and particulate matter while preventing the flow of fluids to the machine pressure monitor at pressures less than 600 mmHg.
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