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510(k) Data Aggregation
K Number
K052445Device Name
DUOPROSS NEEDLE
Manufacturer
DUOPROSS MEDITECH CORPORATION
Date Cleared
2005-12-05
(89 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
DUOPROSS MEDITECH CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DuoProSS Needle device is a sterile hypodermic needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Device Description
The DuoProSS Needle device is a sterile, single use, standard hypodermic needle. The device is available in various Gauges and lengths. Each needle device consists of a stainless steel cannula sealed with epoxy glue into a polypropylene hub. The assembly has a protective polypropylene needle shield. The device is packaged in a peal-back pouch and sterilized by ethylene oxide. The DuoProSS Needle device consists of 4 parts or materials: a stainless steel cannula, a polypropylene hub, epoxy glue and a polypropylene needle guard.
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K Number
K042500Device Name
DUOPROSS SYRINGES
Manufacturer
DUOPROSS MEDITECH CORPORATION
Date Cleared
2005-02-22
(161 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
DUOPROSS MEDITECH CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 1ml DuoPross Insulin Syringe is intended for the injection of insulin into the body.
The DuoPross Syringes device is used to inject fluids into, or withdraw fluids from, the body.
Device Description
The DuoProSS Syringes device is a sterile, single use, standard piston syringe, designed for manual use. The device is available in 1, 1 (insulin), 2, 5, 10, 20 and 60 cc/ml volumes with luer slip or luer lock configurations. Each syringe consists of a calibrated hollow barrel and movable plunger. At the distal end of the syringe is a male connector nozzle for fitting the female connector hub of a single lumen needle. Configurations are supplied with and without the needle already attached to the syringe. The DuoProSS Syringes device consists of 3 parts: a barrel, a plunger, a piston and a needle. The barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The piston is made from Kraton IR, a highly inert isoprene rubber.
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