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510(k) Data Aggregation
K Number
K190663Device Name
Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
Manufacturer
Pajunk GmbH Medizintechnologie
Date Cleared
2019-06-17
(94 days)
Product Code
BSN
Regulation Number
868.5130Why did this record match?
Product Code :
BSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pajunk Epidural MiniFilter NRFit (ISO80369-6) and Epidural MiniFilter LUER (ISO80369-7) is an anesthesia conduction filter. An anesthesia conduction filter is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid. The anaesthesia conduction filter is intended for use for patients that weigh 10kg and above.
Device Description
The Filter is a Class II medical device substantially equivalent to the predicate device (K083451, Portex Epidural Filter) as defined in 21 CFR §868.5130, product code BSN. The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to re-packagers/ medical device manufacturers. The device is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid. It has a flat housing, Female Lock and male connector with rotating locking hub, and a Filter membrane. It is available with either NRFit™ Connector according to ISO 80369-6 or LUER-Connector according to ISO 80369-7.
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K Number
K133004Device Name
VENTED MILLEX -GV, CATHIVEX -GV
Manufacturer
MERCK MILLIPORE LTD.
Date Cleared
2014-03-27
(183 days)
Product Code
BSN
Regulation Number
868.5130Why did this record match?
Product Code :
BSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vented Millex®-GV filter units are syringe filters for sterilization of low volume aqueous solutions for direct patient injection, filtration of laboratory solutions, and filtration of clinical solutions where venting and low protein binding membrane are required or desired.
Cathivex®-GV filter units are in-line gravity fed filters for the sterilization of aqueous solutions for administration via the neuraxial route, filtration of laboratory solutions, and filtration of clinical solutions where venting and low protein binding membrane are required or desired.
Device Description
Vented Millex®-GV and Cathivex®-GV filter units are sterile, non-pyrogenic, single-use filter devices intended for sterilizing aqueous solutions for medical applications. Vented Millex®-GV is designed with a Female Luer Lok™ inlet and a Male Luer slip outlet, and Cathivex®-GV is designed with a Female Luer Lok™ inlet and a Male Luer Lok™ Both devices contain a 0.22um Durapore® hydrophilic filter membrane outlet. constructed from polyvinylidene fluoride (PVDF) and a 0.03um hydrophobic vent membrane constructed from polytetrafluoroethylene (PTFE). The filter membrane is designed to remove particles, microorganisms, microprecipitates and undissolved powders which are larger than 0.22 um. The vent membrane is designed to prevent air locks by automatically venting air introduced upstream. The filter housing material is molded from PVC.
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K Number
K083451Device Name
PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS
Manufacturer
SMITHS MEDICAL ASD, INC.
Date Cleared
2009-03-04
(103 days)
Product Code
BSN
Regulation Number
868.5130Why did this record match?
Product Code :
BSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.
Device Description
The Portex® Epidural Filter is a 0.2um (micron) filter used in epidural anesthesia for the filtration of aqueous drugs and is designed to help protect the patient from injected microorganisms or particulate matter. The Filter is comprised of a 0.2 um supported membrane enclosed in a modified acrylic leak proof transparent housing with male Lucr with a rotating Locking Hub and a female Luer Lock.
The filtration area is 5.25 cm², has a flow rate of ≥ 200ml/Min @ 45 psi and can withstand a pressure of ≥ 115 psi during bolus injections.
The priming volume of the filter is 0.8 ml and the hold up volume is 0.45 ml as determined by weight. The filter has a bubble point of ≥46psi. The filter has 100% bacterial retention.
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K Number
K023892Device Name
MILLEX VV, GV, AND HV SYRINGE FILTER UNITS
Manufacturer
MILLIPORE CORP.
Date Cleared
2003-01-17
(56 days)
Product Code
BSN, FPB
Regulation Number
868.5130Why did this record match?
Product Code :
BSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use as a syringe filter to sterilize, ultraclean, or clarify low volume solutions in direct patient care and pharmacy admixture applications.
Device Description
Not Found
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K Number
K013988Device Name
MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
Manufacturer
MILLIPORE CORP.
Date Cleared
2002-04-04
(121 days)
Product Code
BSN
Regulation Number
868.5130Why did this record match?
Product Code :
BSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use as a syringe filter to sterilize or ultraclean low volume solutions in direct patient care and pharmacy admixture applications.
Device Description
Millex- GP Sterilizing Filter Unit
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K Number
K963717Device Name
MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)
Manufacturer
MILLIPORE CORP.
Date Cleared
1997-06-10
(267 days)
Product Code
BSN
Regulation Number
868.5130Why did this record match?
Product Code :
BSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications.
Device Description
Millex - MP Sterilizing Filter Unit
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K Number
K960928Device Name
SYRINGEFILTER
Manufacturer
ARBOR TECHNOLOGIES, INC.
Date Cleared
1997-04-04
(393 days)
Product Code
BSN
Regulation Number
868.5130Why did this record match?
Product Code :
BSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use is the same.
Device Description
The revised Arbor Medical Syringefilter is as safe and effective as the original. The proposed plastic housings and membrane have passed Class VI testing as did the original housings and membrane. The proposed product is manufactured the same as the original. The method of sterilization is the same as the original version.
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