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510(k) Data Aggregation

    K Number
    K142620
    Device Name
    0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe
    Manufacturer
    Excelsior Medical Corporation
    Date Cleared
    2014-12-12

    (87 days)

    Product Code
    NGT
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Excelsior Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    0.9% Sodium Chloride Injection, USP prefilled syringes are intended for flushing of IV catheters and IV tubing only.
    Device Description
    Excelsior Medical Corporation's 0.9% Sodium Chloride Injection. USP prefilled syringe products are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The saline solution is delivered through the luer lock of a venous access device to maintain catheter patency via hydraulic displacement. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling. total parenteral nutrition, or hemodialysis. 0.9% Sodium Chloride Injection, USP, prefilled syringes are available as follows: - 2.5 mL in 3 mL Syringe - 3 mL in 10 mL Syringe - 5 mL in 10 mL Syringe - 10 mL in 10 mL Syringe The product is intended for use with commercially available valves and catheters fitted with a standard mating luer lock or luer taper.
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    K Number
    K133446
    Device Name
    HEPARIN LOCK / FLUSH SYRINGES
    Manufacturer
    Excelsior Medical Corporation
    Date Cleared
    2014-11-14

    (367 days)

    Product Code
    NZW
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Excelsior Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.
    Device Description
    Excelsior Medical's Heparin Lock Flush, USP devices are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The products contain a solution of heparin sodium, USP and 0.9% sodium chloride, USP. The solution is delivered through the luer lock of a venous access device to maintain catheter patency (lock catheters) between treatments. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling, total parenteral nutrition, or hemodialysis.
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