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510(k) Data Aggregation
K Number
K190328Device Name
HCT Empty EVA Container Pack
Manufacturer
Health Care Technologies
Date Cleared
2019-08-15
(183 days)
Product Code
KPE
Regulation Number
880.5025Why did this record match?
Applicant Name (Manufacturer) :
Health Care Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient. Medication transfer is done using aseptic technique.
Device Description
The subject device is an empty two-port style EVA container available in sizes ranging from 50 mL to 4000 mL. The devices are provided sterile and packaged in multi-pack kits. The intended use is to hold an admixture of compatible fluids for administration to the patient. Medication transfer is done using aseptic technique.
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