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Data / Medical devices / United States / RR Donnelley-Supply Chain Solutions

RR Donnelley-Supply Chain Solutions: FDA-registered device maker in Plover, WI, United States, 19 510(k) clearances and 1 PMA approval

RR Donnelley-Supply Chain Solutions is registered with the FDA (registration 3006371704) in Plover, WI, United States. It lists 30 device types. The FDA files 19 510(k) clearances and 1 PMA approval under its listings, the newest dated September 16, 2022. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch RR Donnelley-Supply Chain Solutions
FDA registration number
3006371704
Address
1600 Disk DR., Plover, WI, United States, 54467
Owner or operator
RRDonnelley (9077726)
Roles
Contract manufacturer, Repackager or relabeler
First device listed
September 19, 2005
Registered through
2026
Brand names listed
10035 Skin Barrier, 10105 SKIN BARRIER FLANGE RED, 10106 SKIN BARRIER FLANGE YELLOW, 10108 SKIN BARRIER, 10522 MIO CLICK SKIN BARRIER, 10561 MIO FLEX SKIN BARRIER, 10571 MIO FLEX SKIN BARRIER, 11482-MIO 2PC CLICK POUCH and more

Devices it lists

DeviceProduct codeClassRoleSource
Anesthesia Conduction KitCAZ2Contract manufactureraccessdata.fda.gov
Automated Insulin Dosing , Threshold SuspendOZO3Contract manufactureraccessdata.fda.gov
Automated Insulin Dosing Device System, Single Hormonal ControlOZP3Contract manufactureraccessdata.fda.gov
Calculator/Data Processing Module, For Clinical UseJQP1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, UrethralGBM2Repackager or relabeleraccessdata.fda.gov
Collector, OstomyEXB1Repackager or relabeleraccessdata.fda.gov
Continuous Glucose Monitor, Implanted, Adjunctive UseQCD3Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
ElectrocardiographDPS2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrocardiograph Software For Over-The-Counter UseQDA2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Repackager or relabeleraccessdata.fda.gov
Glucose Dehydrogenase, GlucoseLFR2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Repackager or relabeleraccessdata.fda.gov
Injection Data Capture DeviceQOG2Repackager or relabeleraccessdata.fda.gov
Insulin Autoantibody KitOCN2Repackager or relabeleraccessdata.fda.gov
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-CounterSAF2Contract manufactureraccessdata.fda.gov
Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone AcetateSBA2Contract manufactureraccessdata.fda.gov
Integrated Continuous Glucose Monitoring System, Factory CalibratedQBJ2Contract manufactureraccessdata.fda.gov
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery SystemsQLG2Contract manufactureraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Repackager or relabeleraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Reagents, Specific, AnalyteMVU1Repackager or relabeleraccessdata.fda.gov
Sensor, Glucose, Implanted, Non-Adjunctive UseQHJ3Repackager or relabeleraccessdata.fda.gov
Sensor, Glucose, InvasiveMDS3Contract manufactureraccessdata.fda.gov
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-InitiatedPZE3Contract manufactureraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Solvent, Adhesive TapeKOX1Repackager or relabeleraccessdata.fda.gov
Syringe, PistonFMF2Repackager or relabeleraccessdata.fda.gov
System, Test, Blood Glucose, Over The CounterNBW2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, TelephoneDXH2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 16, 2022K212217Tempo Smart ButtonQOGSubstantially EquivalentEli Lilly and Companyaccessdata.fda.gov
November 30, 2021K211668KardiaMobile CardDXHSubstantially EquivalentAliveCor, Inc.accessdata.fda.gov
January 24, 2020K191406KardiaMobile, KardiaStationDXHSubstantially EquivalentAliveCor, Inc.accessdata.fda.gov
October 21, 2019K190054BD Insulin SyringeFMFSubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
September 27, 2017K171941FreeStyle Precision Neo Blood Glucose Test StripsNBWSubstantially EquivalentAbbott Diabetes Care, Inc.accessdata.fda.gov
December 9, 2016K162516BD Pen NeedleFMISubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
November 17, 2016K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemNBWSubstantially EquivalentAscensia Diabetes Careaccessdata.fda.gov
September 8, 2014K133584IN TOUCH BLOOD GLUCOSE MONITORING SYSTEMCGASubstantially EquivalentEoshealth, Inc.accessdata.fda.gov
June 23, 2014K130265CONTOUR NEXT EZ BLOOD GLUCOSE METERNBWSubstantially EquivalentBayer Healthcare, LLCaccessdata.fda.gov
December 24, 2013K132511FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEMNBWSubstantially EquivalentAbbott Diabetes Care, Inc.accessdata.fda.gov
September 26, 2013K122370CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITORNBWSubstantially EquivalentBayer Healthcareaccessdata.fda.gov
July 26, 2012K121190CONTOUR NEXT BLOOD GLUCOSE METERLFRSubstantially EquivalentBayer Healthcare, LLCaccessdata.fda.gov
July 27, 2011K110703BD AUTOSHIELD DUO PEN NEEDLEFMISubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
June 15, 2010K092638FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23NBWSubstantially EquivalentAbbott Diabetes Care, Inc.accessdata.fda.gov
May 14, 2010K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring SystemNBWSubstantially EquivalentAbbott Diabetes Care, Inc.accessdata.fda.gov
November 9, 2007K072808SPEEDICATH COMPACTGBMSubstantially EquivalentColoplast Corp.accessdata.fda.gov
April 12, 2006K060470ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080NBWSubstantially EquivalentBayer Healthcareaccessdata.fda.gov
January 27, 2003K023254SPEEDICATHGBMSubstantially EquivalentColoplast Corp.accessdata.fda.gov
April 2, 1984K840269MC 2000 OSTOMY POUCHESEXBSubstantially EquivalentColoplast A/Saccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
June 21, 2018P160048EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEMQCD28March 19, 2026accessdata.fda.gov

Compare with other makers

Updated March 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.