BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RR DONNELLEY-SUPPLY CHAIN SOLUTIONS

    Reg #: 3006371704 · FEI: 3006371704 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    74
    Establishment Types
    2
    Classifications
    30

    Registration Details

    Registration Name
    RR DONNELLEY-SUPPLY CHAIN SOLUTIONS
    Registration Number
    3006371704
    FEI Number
    3006371704
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1600 DISK DR.
    City
    Plover
    State
    WI
    ZIP
    54467
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190054
    PMA Number
    P160048

    Owner / Operator

    Firm Name
    RRDonnelley
    Operator Number
    9077726
    Address
    1600 Disk Drive
    City
    Plover
    State
    WI
    Postal Code
    54467
    Country
    US
    Correspondent
    Lee Rush

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Syringe, Piston FMF
    Collector, Ostomy EXB
    Glucose Dehydrogenase, Glucose LFR
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Solvent, Adhesive Tape KOX
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Electrocardiograph Software For Over-The-Counter Use QDA
    Electrocardiograph DPS
    Continuous Glucose Monitor, Implanted, Adjunctive Use QCD
    Sensor, Glucose, Implanted, Non-Adjunctive Use QHJ
    Reagents, Specific, Analyte MVU
    Glucose Oxidase, Glucose CGA
    Fiber, Medical, Absorbent FRL
    Needle, Hypodermic, Single Lumen FMI
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ
    Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems QLG
    Automated Insulin Dosing , Threshold Suspend OZO
    Automated Insulin Dosing Device System, Single Hormonal Control OZP
    Calculator/Data Processing Module, For Clinical Use JQP
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter SAF
    Sensor, Glucose, Invasive MDS
    Dressing, Wound, Occlusive NAD
    Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate SBA
    Injection Data Capture Device QOG
    Insulin Autoantibody Kit OCN
    Catheter, Urethral GBM
    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated PZE
    Anesthesia Conduction Kit CAZ

    Proprietary Names

    Freestyle Tracker Diabetes Management System Insulin Syringe 324909, 324911 Sensura Relion Ultima Advance Glucose Monitoring System 120115 Brava Adhesive Remover Wipe Contour Next Link Precision Optium Point of Care Blood Glucose test KardiaMobile 12283 MIO430 FLEX POUCH,70MM 10571 MIO FLEX SKIN BARRIER SenSura Mio Original 14305 ASSURA AC SKIN BARRIER XTND WEAR 11856 POUCH SenSura X-pro 12273 MIO430 FLEX POUCH,50MM 10561 MIO FLEX SKIN BARRIER SenSura Mio Click 10522 MIO CLICK SKIN BARRIER 10105 SKIN BARRIER FLANGE RED 11512 FLEX POUCH RED SenSura Mio 120427 MOLDABLE RINGS,4.2MM SenSura Flex 120700 Barrier Strips 11483 MIO430 CLICK POUCH SenSura Mio Flex 10035 Skin Barrier 11482-MIO 2PC CLICK POUCH 12272 MIO FLEX POUCH 11517 FLEX POUCH YELLOW SenSura Mio Pro 10106 SKIN BARRIER FLANGE YELLOW 14554 ASSURA AC POUCH MULTI TRP 10108 SKIN BARRIER Brava Mouldable Rings SenSura Click Eversense Continuous Glucose Monitoring System; Eversense E3 Continuous Glucose Monitoring System Contour & Contour TS Kardia 12L Impala SOFT-TACT DIABETES Flash 3 Freestyle Lite Blood Glucose Monitoring System Interdry Sample Contour Meter Contour Next One BD Pen Needle 320149 FreeStyle Libre 3 Continuous Glucose Monitoring System FreeStyle Libre 2 Flash Glucose Monitoring System Freestyle 6 KardiaMobile Card Freestyle Freedom Blood Glucose Monitoring System Contour Next Link 2.4 BD Single Lumen Hypodermic 329515 FreeStyle Precision Pro System Freestyle Connect Blood Glucose Monitoring System Lingo Gluco Freestyle InsulLinx Blood Glucose Meter Freestyle Blood Glucose Monitoring System 33435 Biatain Silicone Foam Dressing FreeStyle Precision Neo Blood Glucose Monitoring System Contour Next, Contour Next Link, Contour Next One Eversense 365 Continuous Glucose Monitoring (CGM) System Tempo Welcome and Tempo Refill Kits Contour Next Link Link Wireless Precision Xceed Pro Glucose A&B Freestyle precision pro Freestyle Libre Flash Glucose Monitoring System BD Spinal & Epidural Anesthesia Trays K130625 Contour Next EZ Relion Ultima Blood Glucose Monitoring System KardiaMobile 6L Max KardiaMobile 6L K1000

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device