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510(k) Data Aggregation
K Number
K142620Device 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
880.5200Why 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
K133446Device Name
HEPARIN LOCK / FLUSH SYRINGES
Manufacturer
Excelsior Medical Corporation
Date Cleared
2014-11-14
(367 days)
Product Code
NZW
Regulation Number
880.5200Why 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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