BD Medical, a segment of
BD (Becton, Dickinson and Company) 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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