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Food and Drug Administration / Health informatics / Medical equipment / Unique Device Identification / Medical technology / Pharmaceutical industry / GMDN / Medical device / Global Harmonization Task Force / Medicine / Health / Technology


Document Date: 2012-07-10 01:08:51

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City

Rockville / /

Company

Covidien / Boston Scientific / Physio Control Inc. / Medical Device / Penumbra Inc. / Abbott Vascular-Cardiac Therapies/ Guidant Corp. / Strategic National Stockpile / ZOLL Medical Corporation / Smiths Medical ASD Inc. / Pointe Scientific Inc. / /

Country

United States / /

/

Event

Product Recall / Product Issues / /

/

IndustryTerm

Internet access / similar device / healthcare community / counterfeit devices / computerized physician order entry systems / manufacturing practice requirements / prescription devices / software upgrade / certain very low risk devices / highquality medical services / particular device / identification systems / payment information systems / inventory management / electronic health technology / stand-alone software / healthcare professionals / systems / in evaluating applications / information technology / implantable devices / medical services / over-thecounter and low risk devices / broader healthcare community / healthcare providers / problems involving devices / adverse event reports involving devices / appropriate solution / medical devices / similar devices / patient safety involving medical devices / healthcare facilities / implantable device / particular technology / electronic health technologies / cardiovascular device / device identification systems / combination product / particular devices / capture technology / hazardous devices / counterfeit product / retail establishments / implemented device identification systems / /

MedicalCondition

serious injury / injury / /

MedicalTreatment

catheter / /

Organization

FDAaccredited / Health Industry Business Communications Council / Global Harmonization Task Force / office of Management and Budget / Medical Device Recall Authority / International not-for-profit association / Medicare / Standardization/ International Electrotechnical Commission / Center for Devices and Radiological Health / Division of Dockets Management / International Organization / Legal Authority / Food and Drug Administration / office of Regulatory Affairs / Department of Veterans Affairs / Centers for Disease Control and Prevention / ECRI Institute / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / Department of Homeland Security / Department of Defense / Department of Health and Human Services / Unique Device Identification System AGENCY / /

Person

Baxter Colleague / Silver Spring / /

/

Position

physician / Secretary / Major / desk officer / Governor / /

Product

descriptor / UDIs / means hospitals / devices / AND 2009 Descriptor Example / Penumbra / Abbott Vascular-Cardiac Therapies/ Guidant Corp. POWERSAIL Coronary Dilatation Catheters / Device / /

ProgrammingLanguage

C / /

ProvinceOrState

Maryland / /

PublishedMedium

Public Law / /

Technology

bar code / capture technology / information technology / AIDC technology / AIDC technologies / using AIDC technology / particular technology / electronic health technologies / electronic health technology / automatic identification / http / /

URL

www.regulations.gov / /

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