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510(k) Data Aggregation
K Number
K233623Device Name
Praxiject SP 0.9% NaCl
Manufacturer
MedXL Inc.
Date Cleared
2024-02-27
(106 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Product Code :
NGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For vascular access devices flushing only. Sterile fluid path only. Not for use on a sterile field.
Device Description
The Praxiject™ SP 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled volume of 10mL with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. The Praxiject™ SP 0.9% NaCl prefilled syringe is designed to maintain a sterile fluid path only and is individually packaged in a clear flexible plastic film, flow-wrapped heatsealed pouch that functions only as a protective barrier (dust cover). The device is terminally sterilized by gamma irradiation.
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K Number
K231724Device Name
Flush Syringe (Prefilled 0.9% normal saline solution)
Manufacturer
SPM Medicare Pvt. Ltd.
Date Cleared
2023-11-09
(149 days)
Product Code
NGT, REG
Regulation Number
880.5200Why did this record match?
Product Code :
NGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Device Description
Flush Syringe (Prefilled 0.9% normal saline solution) is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The Flush Syringe (Prefilled 0.9% normal saline solution) consists of barrel, plunger, gasket and thread stopper which is used after the intended purpose is achieved to cover the barrel tip of the device. The Flush Syringe (Prefilled 0.9% normal saline solution) is sterile, non-pyrogenic and for single use.
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K Number
K231363Device Name
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
Manufacturer
Hantech Medical Device Co., Ltd.
Date Cleared
2023-09-27
(139 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Product Code :
NGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hantech Pre-filled 0.9% Normal Saline Flush Syringes, are in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the manufacturer for the appropriate device.
Device Description
The Hantech Pre-filled 0.9% Normal Saline Flush Syringes is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The device will be marketed as 10mL syringe with a 3mL, 5mL or10mL fill volume according to the market needs. It is terminally sterilized by steam sterilization. The product has a shelf life of 1 years.
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K Number
K223584Device Name
Pre-Filled Normal Saline Flush Syringe
Manufacturer
Anhui Tianyang Pharmaceutical Co., Ltd.
Date Cleared
2023-08-12
(254 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Product Code :
NGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pre-Filled Normal Saline Flush Syringe is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
Device Description
Pre-Filled Normal Saline Flush Syringe is a polypropylene syringe filled with 0.9% sodium chloride for injection. It contains 3ml, 5ml and 10ml and consists of tip cap, barrel, piston, and plunger. This is a single use, disposable device(s), provided sterile.
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K Number
K230756Device Name
TK Pre-Filled Normal Saline Flush Syringe
Manufacturer
Anhui Tiankang Medical Technology Co., Ltd.
Date Cleared
2023-08-12
(145 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Product Code :
NGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pre-Filled Normal Saline Flush Syringe is intended to be used only for the flushing vascular access devices.
Device Description
Not Found
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K Number
K231161Device Name
0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe
Manufacturer
Becton, Dickinson and Company
Date Cleared
2023-07-21
(88 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Product Code :
NGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices.
Device Description
0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringe is a polypropylene syringe intended to flush indwelling vascular access devices. It is a sterile, single use syringe prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The device is packaged in a film-on-film blister pack and sterilized by gamma irradiation. External sterility of the device enables it to be used in the sterile field. The subject device is available only in 10mL syringe configuration.
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K Number
K231754Device Name
Praxiject 0.9% NaCl
Manufacturer
MedXL Inc.
Date Cleared
2023-07-13
(28 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Product Code :
NGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.
Device Description
The Praxiject™ family of 0.9% NaCl prefilled syringes marketed in the U.S.A. includes the following models: 37043US (3 mL/5 cc), 3704US (5 mL/5 cc), 37053US (3 mL/10 cc), 37055 US (5 mL/10 cc), 3705CUS (10 mL/10 cc), 3705-1US (10 mL/10 cc) and 3706US (20 mL/20 cc). These devices are single use plastic piston syringes with a Luer lock connection fitting, prefilled to labeled volume with 0.9% Sodium Chloride Injection USP, with no preservatives (normal saline), and capped with a plastic tip cap. Model 3705-1US (10 mL/10 cc) is individually packaged in a heat-sealed foil pouch, all other models are individually packaged in a heat-sealed peel pouch. All Praxiject™ 0.9% NaCl prefilled syringes are terminally sterilized by gamma irradiation.
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K Number
K214080Device Name
Pentaflush
Manufacturer
PENTAFERTE ITALIA S.R.L.
Date Cleared
2022-07-20
(205 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Product Code :
NGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pentaflush saline 0.9% NaCl prefilled syringe is intended only for flushing in situ vascular access devices. May be placed on a sterile field. Pentaflush saline 0.9% NaCl prefilled syringe is intended for single patient and single use only.
Device Description
The PentaFlush saline 0.9% NaCl prefilled syringe is a single-use device intended only for flushing in-situ vascular access devices. It is a polypropylene syringe containing an isotonic solution of sterile and non-pyrogenic 0.9% sodium chloride solution. These are ready for use devices that can be placed on sterile field. The product is available in volumes of 3ml, 5ml and 10ml of saline solution in 10 ml syringes, which has a larger diameter in order to avoid that, with the same force applied on the shaft button, the higher pressure generated in the 3ml capacities may cause the vascular catheter to rupture. What differentiates the three versions is the graduated scale, whose maximum capacity coincides with the nominal capacity of each version (3ml, 5ml and 10ml). In all capacities Luer Lock connector of the barrel is closed with a cap. The barrel is filled with a 0.9% NaCl isotonic solution, sterile, pyrogen-free, up to the nominal capacity of the scale; an acitotoxic synthetic rubber piston is assembled to the polypropylene plunger, whose fiducial line is positioned at the nominal capacity of the syringe. The primary packaging of PentaFlush pre-filled syringes can be in: a blister of medical paper and PE/PE peel, or an aluminum pouch of PET/ALL/PE peel. PentaFlush saline 0.9% NaCl prefilled syringes are used only by healthcare professionals, is intended for single patient and single use only. Does not contain preservatives. Not made with natural rubber latex. Rx Only.
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K Number
K220060Device Name
Pre-filled Syringe with Saline
Manufacturer
Jiangsu Caina Medical Co., Ltd.
Date Cleared
2022-06-10
(151 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Product Code :
NGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pre-filled Syringe with Saline is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
Device Description
Not Found
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K Number
K213522Device Name
AMSafe Pre-Filled Normal Saline Flush Syringe
Manufacturer
Amsino International, Inc.
Date Cleared
2022-03-22
(139 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Product Code :
NGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMSafe® Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
Device Description
AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap.
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