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510(k) Data Aggregation
K Number
K203796Device Name
Firefly Needleless Connector
Manufacturer
Date Cleared
2021-07-30
(214 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
PuraCath Medical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PuraCath™ Firefly™ Needleless Connector is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration.
Device Description
The PuraCath Firefly Needleless Connector, Model 9001, is a neutral displacement needleless connector intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids when using a vascular access device. The PuraCath Firefly Needleless Connector is a closed, luer activated device that eliminates the risk of needlestick injuries. The PuraCath Firefly Needleless Connector does not require a specific clamping sequence or technique in order to be used safely. The clear housing and open, fluid filled design enhances flushing practice. The Firefly Needleless Connector may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 mL per second. The Firefly Needleless Connector can be used for seven (7) days and 200 activations. The PuraCath Firefly Needleless Connector is designed to be disinfected using standard of care alcohol wipe down.
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K Number
K151620Device Name
Firefly Peritoneal Dialysis Connector Disinfection System
Manufacturer
Date Cleared
2016-01-20
(218 days)
Regulation Number
876.5630Why did this record match?
Applicant Name (Manufacturer) :
PURACATH MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PuraCath™ Firefly IM Peritoneal Dialysis Connector Disinfecting System is intended for use by PD (peritoneal dialysis) patients as a method of controlling air and touch contamination while performing a solution exchange dialysis patiens as a nethod of connector Disinfecting System is comprised of Firefly™ UV Purification Device, FireflyTM Transfer Catheter, FireflyTM Luer Cover, and FireflyTM 99% IPA bottle.
The effectiveness of the PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System was tested in viro against The enectivelless of the Funceoccus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Streptococus Staphylococcus autous, Staphylococcus aureus, and Candida albicans yielding ≥ 4log reduction in microorganisms.
The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System may be used in the home or a healthicare facility.
Device Description
The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System provides a way for patients to ensure the cleanliness of the fluid connections associated with ambulatory peritoneal dialysis. The system accomplishes cleaning with a combination of alcohol, flushing with sterile dialysate, and ultraviolet (UV) light. The System consists of the components shown below.
The Firefly UV Purification Device is a multi-year reusable device which helps to clean the connection between the Firefly Transfer Catheter and the dialysate Y-set (Y-set). The UV Purification Device is powered by off-the-shelf, replaceable AA batteries. The UV Purification Device directs ultraviolet (UV) light through the Transfer Catheter connector. UV Purification Device uses lights and an audible alert to indicate device status.
The Firefly Transfer Catheter is a sterile, 6 month use, disposable device providing communication between the indwelling patient catheter and the Y-set. A proprietary, UV transparent control valve on the end of the Transfer Catheter allows for draining and filling the peritoneum. The control valve is actuated manually, adjustable between fully open and fully closed. The Transfer Catheter also has a flush feature. The flush feature allows for flushing of air and potential contaminants from the Y-set prior to fluid exchange.
The Firefly Luer Cover is a 6 month use, disposable, UV transparent component designed to protect the Transfer Catheter connector between uses and to aid in keeping the control valve closed.
The Firefly IPA Dropper Bottle provides a convenient way to apply 99% IPA solution to the inside of the Y-set and Transfer Catheter connectors.
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