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510(k) Data Aggregation
K Number
K212525Device Name
Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
Manufacturer
Date Cleared
2022-08-19
(373 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Advcare Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Advcare Vial Direct to Bag (VDB) Needle-free Admixture devices are intended for drug reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution and attaching an IV set to administer influsion liquid to patient. The devices are provided as single-use, sterile, and non-pyrogenic products. The VDB-13 & 20 has an integrated vial adaptor that is used to reconstitute and admix drugs from a drug vial into the solution IV bag. The devices are intended for use in healthcare environments by clinically trained healthcare professional providers to aid and support prescribed treatment and therapy.
Device Description
Advcare IV fluid transfer Vial Direct to Bag (VDB) VDB-13 & 20 Needle-free Admixture Devices are designed for drug reconstitution and transfer of fluids from drug vials into IV bag containing infusion solution. The VDB-13 & 20 serve as a fluid pathway for standard IV set to administer fluid to patient while minimizing exposure to drug aerosols and spills. The VDB-13 & 20 has an integrated vial adaptor that is used to reconstitute and admix drugs from a drug vial into the solution IV bag. Both IV fluid transfer system designs consist of a body, piercing spike, spike cover, IV port, and twist-off for the IV administration set. The VDB 13mm and 20mm has an integrated Vial Adaptor for access to the drug/solution vial. Both system transfer drug into an IV bag and to an external IV administration set to administer fluid to patient. The products do not contain any medicinal substances, and can be used with standard drug vials. It is intended for use in healthcare facilities by care-giver to aid and support prescribed treatment and therapy.
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