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Chemfort® Catheter 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 administration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort® Catheter Adaptor prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

The Chemfort® Catheter Adaptor enables drug transfer to the catheter, thus allowing drug administration to the patient's urinary bladder. The use of elastomeric seals of the Chemfort® Catheter Adaptor prevents hazardous drug contamination of healthcare professionals, the patient, and the environment. The Chemfort® Catheter Adaptor is an addition to the cleared Chemfort® system (K192866). The Catheter Adaptor provides closed system protection during the following procedures: - a) Drug transfer from a standard luer lock syringe to the Catheter Adaptor through the Chemfort® Syringe Adaptor (K192866). - b) Closed system drug administration to the urinary bladder, through a urinary catheter. The Catheter Adaptor fits a wide range of standard catheter sizes and converts an open catheter connection to a closed Chemfort® connection. The Chemfort® Catheter Adaptor allows the healthcare professional to have the option for safe drug administration to the urinary catheter and safe disconnection of the Chemfort® Syringe Adaptor (K192866) from the patient's urinary catheter.

The OnGuard®2 Chemfort™ Closed Administration 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 administration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. OnGuard®2 Chemfort™ Closed Administration prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

The OnGuard®2 Chemfort™ Closed Administration (CADM) devices allow drug transfer to the IV bag and drug administration to the patient. The use of elastomeric seals in CADM prevents hazardous drugs contamination of healthcare professionals, the patient and the environment. The OnGuard®2 Chemfort™ Closed Administration contains four devices that connect between infusion containers and primary sets: - Bag Adaptor Chemfort™ Port (BACP) - Closed Y Inline Set (Y-Set) - Closed IV Secondary Set (Secondary) - Closed Adaptor Spike Port (CASP) CADM devices are an addition to the cleared Chemfort™ system (K192866). CADM provides closed system protection during the following procedures: - 1) Drug transfer to a container (e.g. IV bag) through the Chemfort™ Syringe Adaptor (K192866) and CADM Bag Adaptor Chemfort™ Port (BACP). - 2) Drug administration, with one of the CADM sets after it is attached to the BACP and creates a closed system.

Tevadaptor® is a 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, compounding and administration, minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system. The I.V. Administration set is comprised of various components such as: Spike, tubing, clamp, ULTRASITE® needless injection site (Y-site), 'twist-off' and Luer connection. The I.V. Administration set is part of the Tevadaptor® closed system transfer device (CSTD) and is intended to interact with Tevadaptor® and/or Chemfort™ system's Syringe Adaptor (SA), Syringe Adaptor Lock (SAL) and Luer Lock Adaptor (LLA) components that were cleared under K192866. The Tevadaptor® and Chemfort™ CSTD are intended to protect the healthcare professional, the patient and the environment during preparation, reconstitution, compounding and administration of hazardous drugs in the form of liquid, vapor or aerosol. The Tevadaptor® and/or Chemfort™ SA connects to the Tevadaptor® port located on the I.V. Administration set's Spike component. After the connection is made, a fluid path is opened which allows to inject of the drug to the patient's IV bag. The Tevadaptor® and/or Chemfort™ LLA connects to any female luer connection located on the I.V. Administration set to create a Tevadaptor® port connection that enables the Tevadaptor® and/or Chemfort™ SA to administer the drug directly to the patient. The purpose of this submission is to add five new designs of I.V. Administration Sets to the Tevadaptor® and/or Chemfort™ Closed System Transfer Device (CSTD) that was cleared for sale in the US under K192866, the descriptions of the added sets, subject of this submission: - Tevadaptor® IV Secondary Safety Set with ULTRASITE® - Tevadaptor® IV Secondary Safety Set . - Tevadaptor® Bag Adaptor LL ● - Tevadaptor® Bag Adaptor LL with ULTRASITE® . - . Tevadaptor® Bag Adaptor SP with ULTRASITE® All of the components used in the five new I.V. Administration Sets were previously used in the predicate device cleared under K121269, except for the Spike component which has been redesigned in comparison to the predicate's Spike component that was cleared under K121269. The redesigned Spike component is substantially equivalent to the reference device, Chemfort™ Bag Adaptor SP's Spike component, which was cleared under K192866. The Spike component of both the IV Administration Set and of the reference device are identical in terms of design and raw material.

Chemfort™ is a 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, minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort™ prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

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 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. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron. The components of the 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.