Becton Dickinson's BD Medical Receives FDA Clearance Under Newly Created ONB Product Code
BD Medical, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the BD PhaSeal™ Closed System Transfer Device (CSTD) under the newly created ONB code. The BD PhaSeal System is the first and only cleared CSTD under the new code, which was created for devices that have specific indications for use with antineoplastic and other hazardous drugs.
The FDA clearance was based on three criteria: no escape of hazardous drug or vapor concentration, no transfer of environmental contaminants, and prevention of microbial ingress. The BD PhaSeal System is the only CSTD currently available that meets all three of these standards.
The FDA created the new ONB code because it recognized that a new product code would be in the best interest of public health and wanted to improve the information available to users of devices that have specific indications for use with antineoplastic and other hazardous drugs. The BD PhaSeal System obtained ONB clearance through validated third-party evidence. Please visit www.bd.com/PhaSeal for more information.
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