BD Medical announces that the US FDA has cleared the BD PhaSeal, a closed system transfer device (CSTD) that reduces exposure to hazardous parenteral medications from preparation to administration. The BD PhaSeal received FDA clearance under the new ONB code, created for devices that have specific indications for use with antineoplastic and other hazardous drugs. A CSTD must completely prevent escape of hazardous drug or vapor concentration, transfer of environmental contaminants, and microbial ingress to qualify under the ONB code. The FDA gave BD PhaSeal ONB clearance based on validated third-party evidence.
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