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510(k) Data Aggregation
K Number
K121803Device Name
INTRAVASCULAR ADMINISTRATION SET
Manufacturer
ACTA MEDICAL LLC
Date Cleared
2012-12-19
(183 days)
Product Code
FPA, DEV
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
ACTA MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acta Medical Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Acta Medical infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.
Device Description
Acta Medical, LLC Intravascular administration set is sterile/pvrogen free. non-DEHP PVC tubing with the following combination of components.
- Universal Spike.
- Drip chamber with 15 micron filter.
- Non-DEHP PVC tubing.
- Flow Regulator.
- Roller clamp.
- Slide clamp.
- Luer locks.
- Filters.
- Latex free "Y" site or pre-approved needleless "Y" site for secondary infusions or medication administration.
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K Number
K121161Device Name
EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER
Manufacturer
ACTA MEDICAL LLC
Date Cleared
2012-07-13
(87 days)
Product Code
KPE
Regulation Number
880.5025Why did this record match?
Applicant Name (Manufacturer) :
ACTA MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An Empty Container with sterile fluid pathway used to store intravenous solution for administration to patient. Medication transfer in and out of the container is done using aseptic technique.
Device Description
Acta Medical Empty EVA Solution Container is designed to hold intravenous fluid in a single chamber or in dual chambers separated by a separating partition. Empty EVA Solution Container and Empty EVA Dual Chamber Solution Container has fill ports to fill single and dual chambers, latex free injection port for additions of injectable additives and a spike port to connect intravascular administration tubing. The fill port tubing has a sealing clamp to secure the contents during storage post filling and prior to their administration.
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