4b03a988-8704-4d47-b506-cb9f28181076UpdatePublished32018-07-202017-01-20In Commercial Distribution50885425598562PackageGS11088542559856425In Commercial DistributionCASE10885425598564PrimaryGS1CARDINAL HEALTHSMAOCAMWCDSMAOCAMWCD961027315Cardinal Health 200, LLC1STERILE AMNIOCENTESIS PACKfalsetruefalsetruefalsetruetruefalsetruetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse35496Amniocentesis kit, medicated, single-useA collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, dressings, and pharmaceuticals. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. This is a single-use device.falseActiveHIOSampler, amniotic fluid (amniocentesis tray)Storage Environment Temperaturetruefalse