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510(k) Data Aggregation
K Number
K171796Device Name
Vial Adapter 15mm
Manufacturer
Medimop Medical Project Ltd.
Date Cleared
2017-10-12
(118 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Medimop Medical Project Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vial Adapter 15mm is indicated for the transfer and mixing of drugs contained in vials
Device Description
The vial adapter is a one piece molded polycarbonate device that is used to aide in the reconstitution and transfer of drugs contained in vials. The sterile device pierces the elastomeric septum of a drug vial with its integrated spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the "legs" of the vial adapter. The opposing side of the vial adapter contains a Luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the drug vial. After drug removal, the syringe is removed and the vial adapter is properly discarded with the drug vial.
The proposed device, Vial Adapter 15mm, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy.
The proposed device, Vial Adapter 15mm is a 15mm version of the currently available 13mm Vial Adapter or 20mm Vial Adapter. The device consists of a piercing spike and integrated Vial Adapter (15mm) for access to the drug/solution vial.
The device does not contain any medicinal substances, and can be used with standard drug vials. It is intended for use in healthcare facilities or in home environment by a care-giver to aid and support prescribed treatment and therapy.
The device does not contain any medicinal substances, and can be used with standard drug vials.
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K Number
K170095Device Name
Vial2Bag Direct Connect
Manufacturer
Medimop Medical Project Ltd.
Date Cleared
2017-03-08
(56 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Medimop Medical Project Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV bag and an external IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.
Device Description
The proposed device, Vial2Bag Direct Connect, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy.
The proposed device. Vial2Bag Direct Connect is available with 13mm Vial Adapter or 20mm Vial Adapter. The device consists of the Vial2Bag piercing spike and cover, the twist-off connector and an integrated Vial Adapter (13mm or 20mm) for access to the drug/solution vial.
Up to 3 Vial2Bag Direct Connect can be consecutively connected by inserting the spike of one device into the twist off connector of the previous device.
The device does not contain any medicinal substances, and can be used with standard drug vials.
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