RR DONNELLEY-SUPPLY CHAIN SOLUTIONS

FDA Device Registration & Listing · Plover, WI, US · Registration 3006371704

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006371704
FEI Number
3006371704
Entity Name
RR DONNELLEY-SUPPLY CHAIN SOLUTIONS
City/State/Country
Plover, WI, US
Establishment Address
1600 DISK DR., Plover, WI 54467, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
RRDonnelley (Owner Number: 9077726)
Owner / Operator Contact Address
1600 Disk Drive, Plover, WI 54467, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-09-26
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-09-23
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 2015-03-11
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-09-26
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-09-26
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-09-26
KOX Solvent, Adhesive Tape General, Plastic Surgery Class 1 878.4730 2015-04-15
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2014-09-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2014-09-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-11-20
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-09-26
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-09-26
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2025-06-16
QDA Electrocardiograph Software For Over-The-Counter Use Cardiovascular Class 2 870.2345 2025-06-16
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2025-06-16
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 2013-03-21
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-09-26
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-09-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-09-26
QCD Continuous Glucose Monitor, Implanted, Adjunctive Use Unknown Class 3 N/A 2023-07-19
QHJ Sensor, Glucose, Implanted, Non-Adjunctive Use Unknown Class 3 N/A 2023-07-19
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-09-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-09-26
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2024-06-19
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2005-09-19
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2005-09-19
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2020-08-19
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-10-19
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-10-19
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2020-09-09
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-09-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2020-09-09
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-09-26
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2015-04-15
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2014-09-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2014-09-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2016-12-16
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2016-12-16
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2020-09-23
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2025-07-02
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2025-07-02
QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Clinical Chemistry Class 2 862.1355 2025-07-02
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-10-19
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-10-19
QDA Electrocardiograph Software For Over-The-Counter Use Cardiovascular Class 2 870.2345 2023-08-26
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2023-08-26
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2023-08-26
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-09-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-09-26
OZO Automated Insulin Dosing , Threshold Suspend Unknown Class 3 N/A 2020-04-24
OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown Class 3 N/A 2020-04-24
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2014-09-05
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2013-08-30
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2013-08-30
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2013-08-30
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-08-30
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-09-26
SAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter Clinical Chemistry Class 2 862.1355 2024-06-19
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-09-26
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-09-26
MDS Sensor, Glucose, Invasive Unknown Class 3 N/A 2016-10-10
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-09-26
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-09-26
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2015-04-15
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2016-05-09
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-04-24

Official Correspondent

Lee Rush

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RRDonnelley
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3040389677 RRDONNELLEY Dongguan Guangdong, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12
K973662 Boehringer Mannheim Corp. ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS 1997-12-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06 Abbott Laboratories Medisense Products 2
Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006371704. Last updated year: 2026. Please use registration number 3006371704 when referencing this establishment in official correspondence.
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