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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?
Applicant Name (Manufacturer) :
MedXL Inc.
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
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?
Applicant Name (Manufacturer) :
MedXL Inc.
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
K192414Device Name
Praxiject 0.9% NaCl
Manufacturer
MedXL Inc.
Date Cleared
2020-02-13
(162 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
MedXL Inc.
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™ 0.9% NaCl prefilled syringe is a single use plastic piston syringe 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. Each prefilled syringe is individually packaged in a heat-sealed pouch and terminally sterilized by gamma irradiation.
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K Number
K171109Device Name
Praxiject 0.9% NaCl
Manufacturer
MedXL Inc.
Date Cleared
2017-12-21
(251 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
MedXL Inc.
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™ 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled fill volume with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. Each prefilled syringe is individually packaged in a plastic peel pouch and terminally sterilized by gamma irradiation.
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