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510(k) Data Aggregation
K Number
K033099Device Name
ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109
Manufacturer
Date Cleared
2003-10-16
(17 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
APPLIED DIABETES RESEARCH, INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ADR THINSet Infusion Set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood or blood products.
Device Description
The ADR THINSet Insulin Infusion Set facilitates the flow of medication from an infusion pump reservoir into the subcutaneous tissue of the user. The infusion set consists of a female luer, tubing, Needle Grip with introducer needle and Base Assembly. The Base Assembly consists of three components: the Needle Grip, Connector and Base. The Needle Grip contains the 26 guage introducer needle that penetrates the subcutaneous tissue. The infusion set tubing attaches to the Connector. The Connector may be removed from the Base. The Base houses the 24 gauge Cannual and has a medical grade adhesive dressing attached to the bottom. The infusion set is packaged sterile in a Tray Pack. The infusion set is available with 23 and 43 inch tubing lines and 6 and 9 mm Cannulas.
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K Number
K024056Device Name
SURESET 3.0 ML RESERVOIR, MODEL 24-103
Manufacturer
Date Cleared
2003-01-17
(39 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
APPLIED DIABETES RESEARCH, INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SureSet 3.0 ml Reservoir is indicated for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not indicated for use with blood or blood products.
Device Description
The SureSet Reservoir is a single use 3.0 ml piston syringe. It consists of a hollow barrel, movable plunger with O-rings for sealing and a male Luer lock fitting at the distal end. This device is used in conjunction with an external infusion pump and infusion set (e.g. SmartSet Insulin Infusion Device cleared under K012429) to deliver medications, including insulin, subcutaneously. The male Luer lock fitting of the reservoir is connected to the female Luer fitting of an infusion set. The reservoir is placed in an external infusion pump. The SureSet Reservoir is available with a 22 gauge cannula (Model 24-103) or without a cannula (Model 24-104).
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K Number
K012429Device Name
SURESET INFUSION SET, MODEL 8023
Manufacturer
Date Cleared
2001-11-06
(98 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
APPLIED DIABETES RESEARCH, INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump
Device Description
The SmartSet Insulin Infusion Device is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. Its introducer needle is inserted at a right angle into the subcurtaneous tissue of the infusion site and then withdrawn to leave the indwelling catheter in place. The pump end of the Smart-Set tubing is attached to an external infusion pump. Following the pump manufacturer's instructions, the tubing is primed until medication drips from the connector needle. The SmartSet end of the tubing is aligned with the SmartSet hub and then firmly locked together.
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