Specifications include, but are not limited to: a. ParaGard® T 380A Intrauterine Copper Contraceptive (ParaGard®) Single (NDC 51285-0204-01) that is a T-shaped intrauterine device (IUD), measuring 32 mm horizontally and 36 mm vertically, with a 3 mm diameter bulb at the tip of the vertical stem; b. A monofilament polyethylene thread tied through the tip, resulting in two white threads, each at least 10.5 cm in length, to aid in detection and removal of the device; c. A T-frame made of polyethylene with barium sulfate to aid in detecting the device under x-ray. ParaGard® also contains copper: approximately 176 mg of wire coiled along the vertical stem and a 68.7 mg collar on each side of the horizontal arm. The total exposed copper surface area is 380 ± 23 mm²; d. Weighs less than one (1) gram; e. No component of ParaGard® or its packaging containing latex; f. Packaged together with an insertion tube and solid white rod in a Tyvek® polyethylene pouch that is then sterilized. A moveable flange on the insertion tube aids in gauging the depth of insertion through the cervical canal and into the uterine cavity; g. FDA approved; h. Includes a ParaGard® appointment card, Patient Package, and Prescribing Information Pamphlets; i. Provided in a single package size (NDC 51285-0204-01) with a five year shelf life expiration date from the time of procurement; and j. A pedigree paper or an electronic pedigree for each distribution of ParaGard® as required by section 499.01212, Florida Statutes. The Department is a 340B entity; therefore, the vendor must provide ParaGard® at 340B pricing.
