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Chemfort® 28-day 20 mm Vial Adaptor is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during preparation, reconstitution, compounding and administration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

Chemfort® 28-day 20 mm Vial Adaptor prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 28 days or 10 activations.

The Chemfort® Closed System Transfer Device (CSTD) is a system of components that allows the reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion solution container. The Chemfort® CSTD prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter.

The components of the predicate Chemfort® CSTD system are:

• Vial Adaptor 20 mm with 13 mm Vial Converter
• Vial Adaptor 28 mm
• Vial Adaptor 32 mm
• Syringe Adaptor
• Syringe Adaptor Lock
• Luer Lock Adaptor
• Bag Adaptor SP

Each of the Chemfort® system components is available separately.

This submission introduces a new version of the 20mm Vial Adaptor to the Chemfort® CSTD system, called the Chemfort® 28-day 20 mm Vial Adaptor, as a range extension. This new Vial Adaptor differs from the predicate Vial Adaptor only with respect to the usage time limitation, which is extended from 7 to 28 days, but with the same limit of 10 activations. This change is reflected in the Indications for Use statement and the device labeling.

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