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510(k) Data Aggregation
K Number
K120420Device Name
STERILE BLUNT FOR SINGLE USE
Manufacturer
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
Date Cleared
2012-10-18
(251 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Blunt for Single Use includes two models, which are blunt fill needle and blunt plastic cannula.
The blunt fill needle is used in conjunction with a syringe to penetrate the vial/ampoules stopper intended for injection or aspiration of fluid.
The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.
Device Description
The proposed device, Sterile Blunt for Single Use, includes two models, which are blunt fill needle and blunt plastic cannula.
The blunt fill needle consists of a stainless steel needle tube, a hub and a sheath. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. It is not intended to access the injection site on I.V. System.
The blunt plastic cannula consists of molded plastic blunt tipped cannula, a hub and a sheath. It is used to replace hypodermic needles to prevent from the unintended injury by metal needle.
Both two models are available in either EO sterilized to achieve a Sterilized to achieve a Sterility Assurance Level (SAL) of 106. The proposed device is sealed in a sterility maintenance package to maintain its sterility during its shelf life of three (3) years.
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K Number
K090929Device Name
STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE
Manufacturer
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
Date Cleared
2009-06-12
(71 days)
Product Code
FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Hypodermic Syringe for Single Use is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical.
The sterile Insulin Syringe for single use with fixed needle is a device is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin, and for the injection of insulin into parts of the body below the surface skin.
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Device Description
Not Found
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