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Closed System Drug Transfer Device (CSTD) for safe preparation, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs

The EQUASHIELD® Closed System Drug Transfer Device (CSTD) is intended for safe preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended and unintended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs. EQUASHIELD® CSTD is a sterile, single use system. The various system components are listed in the table below: | Name | Description | |-----------------------------------------|-------------------------------------------------------------------------| | Syringe Unit | Syringe for drug transfer | | Vial Adaptor | Adaptor to the drug vial | | Spike Adaptor & Spike Adaptor<br>180 | Adaptor for the IV bag for injection and for infusion<br>administration | | Spike Adaptor W & Spike Adaptor<br>W180 | Adaptor for the IV bag for withdrawal | | Luer Lock Adaptor 1 | Adaptor for injection into IV lines | | Luer Lock Adaptor 2 | Adaptor for injection and withdrawal for IV lines | | Female Luer Lock connector | Connector for standard IV tubing set ports | | Protective Plug | A plug to protect connectors during transportation | | Tubing sets | Accessory for injection into an IV line | | Reconstitution Set Accessory | Accessory for reconstituting powdered drugs | | Luer Lock Adaptor 1C | Adaptor for injection into catheters | | Luer Lock Adaptor 1DC | Adaptor for medication transfer between<br>EQUASHIELD® Syringe Units | | Male Priming Connector | Connector for priming of IV line | The above components are combined to create a system and are not intended to be used individually. The variable sterile air chamber integrated into the encapsulated syringe provides selfcontained pressure equalization. The connector unit is welded to the syringe and uses the double-membrane method as high efficiency microbial barrier and for leak-proof and drug residual-free connections to the adaptors of the system. The double membrane prevents the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, spills and also prevents microbial ingress up to 7 days. The purpose of this submission is to obtain FDA clearance for new system components and material changes for previously cleared components and to revise the indication for use for clarity with respect to the functionality of the Syringe Unit.

Closed System drug Transfer Device (CSTD) for preparation, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and also prevents microbial ingress up to 7 days.

Equashield is a sterile, single use, Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs. The Equashield closed system consists of a piston syringe (Syringe Unit), an adaptor to the medication vial (Vial Adaptor), an adaptor for the IV bag for injection (Spike Adaptor), an adaptor for the IV bag for withdrawal (Spike Adaptor-W), adaptors for injection into IV lines, syringes, or catheters (Luer Lock Adaptors). Nursing Pair connectors for standard IV tubing set ports (Female Luer Lock Connector and Male Luer Lock Connector), a Protective Plug, an adaptor for injection into an IV line with a Y-Site Tubing Set, or Secondary Tubing Accessory, and a Reconstitution Tubing Set for reconstituting powder drugs. The variable sterile air chamber integrated into the encapsulated syringe provides self-contained pressure equalization. The connector unit is welded to the syringe and uses the double-membrane method as high efficiency microbial barrier and for leak-proof and drug residual-free connections to the adaptors of the system. The double membrane seals off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, spills and also prevents microbial ingress up to 7 days. The purpose of this submission is to add new components to the system including a thin size for components, introduce different material to the components and make labeling changes.

Closed System drug Transfer Device (CSTD) for preparation, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and also prevents microbial ingress up to 7 days.

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Closed System drug Transfer Device (CSTD) for safe preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress.

The Equashield system consists of a piston syringe (Syringe Unit), an adaptor to the medication vial (Vial Adaptor), an adaptor for the infusion bag for injection (Spike Adaptor 1), an adaptor for the infusion bag for withdrawal (Spike Adaptor W), an adaptor for female luer lock ports (Luer Lock Adaptor), nursing pair connectors for male and female luer lock ports (Female LL Connector and Male LL Connector), and a protective plug (Protective Plug). The Equashield closed system consists of 8 components that are dedicated to each other to create a system. The components are not intended to be used individually. Vial Adaptor is 48 x 31mm, 23mm at distal end. Plug is 51 x 17mm large. Female luer lock is 50 x 23 mm with a 5.2mm ID. Male luer lock is 42 x 21mm with a 15mm depth. Spike Adaptor is 75 x 42 mm and the height is 22mm.

The EQUASHIELD™ System reconstitution and transfer system is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs for intravenous infusion or injection. The EQUASHIELD™ System has an additional Protective Plug accessory which functions as a feature that mechanically prohibits the entrance of any objects into the EQUASHIELD™ System by physically blocking and protecting the system's connector ports.

The EQUASHIELD™ System Protective Plug is used as a "cork" for blocking EQUASHIELD™ connector openings, thus providing the system with further protection, mainly during the transportation and conveying of the EQUASHIELD™ System together with other accompanied items (used routinely by the hospital), where EQUASHIELD™ components might be squeezed in a transportation container together with other items which could accidently cause damage due to penetration of such items into the EQUASHIELD™ System's connector ports. The Protective Plug is inserted into the EQUASHIELD™ connector ports' openings and mechanically prohibits entrance of any accompanied items.