5 results
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7ms
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Sources: EU EUDAMED, US FDA
Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps
FDA Enforcement
Class III
·Terminated·OriGen Biomedical, Inc.·April 21, 2021
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
FDA Enforcement
Class III
·Terminated·Teleflex Medical·July 24, 2019
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
FDA Enforcement
Class III
·Terminated·Teleflex Medical·July 24, 2019
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
FDA Enforcement
Class III
·Terminated·C.R. Bard, Inc.·August 10, 2016
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.
FDA Enforcement
Class III
·Terminated·Acon Laboratories, Inc.·August 5, 2015