Rr Donnelley Global Turnkey Solutions

FDA Filings

This page includes the latest FDA filings for Rr Donnelley Global Turnkey Solutions. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006371704
• FEI Number: 3006371704
• Name: RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS
• Owner & Operator: RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS
• Contact Address: 1600 Disk Drive ; Plover WI 54467 US
• Official Correspondent:
  • Kari Wroblewski
  • x-715-3436940-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1600 DISK DR. ; Plover, WI 54467 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device

• Registration Number: 3013160357
• FEI Number: 3013160357
• Name: Kate Twomey
• Owner & Operator: RR Donnelley Global Turnkey Solutions
• Contact Address: 6315 W BY NORTHWEST BLVD ; Houston TX 77040 US
• Official Correspondent:
  • KATE TWOMEY
  • 1-713-3541397-1397
• US Agent:
  • Kate Twomey
  • RR Donnelley
  • 713 1713354 1397
  • kate.twomey@rrd.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6315 West by Northwest Blvd Houston; Houston, TX 77040 US
• Establishment Type: Repack or Relabel Medical Device

• Registration Number: 3006534878
• FEI Number: 3006534878
• Name: Kate Twomey
• Owner & Operator: RR Donnelley - Global Turnkey Solutions
• Contact Address: 30 Toh Guan Road #05-01 ; Singapore SG-NOTA 608840 SG
• Official Correspondent:
  • Kelvin Wong
  • 065-6672-7881-x
• US Agent:
  • Kate Twomey
  • RR Donnelley
  • 713 1713354 1397
  • kate.twomey@rrd.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6315 West by Northwest Blvd Houston; Houston, TX 77040 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
KZJ Kate Twomey [RR Donnelley Global Turnkey Solutions]	Bio Bag	2018-07-19
JTS Kate Twomey [RR Donnelley Global Turnkey Solutions]	Droppers	2018-07-19
JTO Kate Twomey [RR Donnelley Global Turnkey Solutions]	Ninhydrin, Nitrate A and B, Oxidase, PRY, Voges Proskauer A and B	2018-07-19
JTO Kate Twomey [RR Donnelley Global Turnkey Solutions]	Dropper reagents - 10% KOH, 10% Na Desosycholate, Catalase, DMACA Indole, FeCI(3), Indole, Methylene Blue Loeffler,	2018-07-19
IDC Kate Twomey [RR Donnelley Global Turnkey Solutions]	Droppers	2018-07-19
GBX Kate Twomey [RR Donnelley Global Turnkey Solutions]	Clay Adams	2018-07-19
PMN K920536 | LIO Kate Twomey [RR Donnelley Global Turnkey Solutions]	Affirm? VPIII Ambient Temperature Transfer System	2018-07-11
PMN P160030 | PZE RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle Libre Flash Glucose Monitoring System	2017-10-12
PMN K160682 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Next One	2016-12-16
PMN K160682 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Next One	2016-12-16
PMN K142928 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	FreeStyle Precision Neo Blood Glucose Monitoring System	2016-05-09
NAD RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	33435 Biatain Silicone Foam Dressing	2015-04-15
KOX RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	120115 Brava Adhesive Remover Wipe	2015-04-15
FRL RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Interdry Sample	2015-04-15
EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Sensura	2015-03-11
PMN K132511 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle precision pro	2014-09-08
PMN K132511 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle precision pro	2014-09-08
PMN K132511 | JQP RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle precision pro	2014-09-08
PMN K132511 | JIN RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle precision pro	2014-09-08
PMN K130265 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	K130625 Contour Next EZ	2014-09-08
PMN K130265 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	K130625 Contour Next EZ	2014-09-08
PMN K122370 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Next Link	2014-09-08
PMN K122370 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Next Link	2014-09-08
PMN K121190 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Next Link Link Wireless	2014-09-08
PMN K121190 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Next Link Link Wireless	2014-09-08
PMN K121190 | JJX RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Next Link Link Wireless	2014-09-08
PMN K060470 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Meter	2014-09-08
PMN K060470 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Meter	2014-09-08
PMN K131358 | FMI RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	BD Pen Needle 320149	2014-09-05
PMN K110703 | FMI RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	BD Single Lumen Hypodermic 329515	2014-09-05
PMN K024112 | FMF RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Insulin Syringe 324909, 324911	2014-09-05
PMN K130094 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	FreeStyle Precision Pro System	2013-08-30
PMN K130094 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	FreeStyle Precision Pro System	2013-08-30
PMN K130094 | JQP RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	FreeStyle Precision Pro System	2013-08-30
PMN K130094 | JIN RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	FreeStyle Precision Pro System	2013-08-30
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	SenSura X-pro	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	SenSura Mio	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	SenSura Mio Pro	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	SenSura Mio Original	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	SenSura Mio Flex	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	SenSura Mio Click	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	SenSura Flex	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	SenSura Click	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Brava Mouldable Rings	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	14554 ASSURA AC POUCH MULTI TRP	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	14305 ASSURA AC SKIN BARRIER XTND WEAR	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	12283 MIO430 FLEX POUCH,70MM	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	12273 MIO430 FLEX POUCH,50MM	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	12272 MIO FLEX POUCH	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	120700 Barrier Strips	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	120427 MOLDABLE RINGS,4.2MM	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	11856 POUCH	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	11517 FLEX POUCH YELLOW	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	11512 FLEX POUCH RED	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	11483 MIO430 CLICK POUCH	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	11482-MIO 2PC CLICK POUCH	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	10571 MIO FLEX SKIN BARRIER	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	10561 MIO FLEX SKIN BARRIER	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	10522 MIO CLICK SKIN BARRIER	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	10108 SKIN BARRIER	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	10106 SKIN BARRIER FLANGE YELLOW	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	10105 SKIN BARRIER FLANGE RED	2013-03-21
PMN K840269 | EXB RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	10035 Skin Barrier	2013-03-21
PMN K092602 | NBW Kate Twomey [RR Donnelley - Global Turnkey Solutions]	Freestyle	2012-10-24
PMN K092602 | LFR Kate Twomey [RR Donnelley - Global Turnkey Solutions]	Freestyle	2012-10-24
PMN K051213 | NBW Kate Twomey [RR Donnelley - Global Turnkey Solutions]	Xceed	2012-10-24
PMN K051213 | LFR Kate Twomey [RR Donnelley - Global Turnkey Solutions]	Xceed	2012-10-24
PMN K092638 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle 6	2012-10-19
PMN K092638 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle 6	2012-10-19
PMN K092602 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Flash 3	2012-10-19
PMN K092602 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Flash 3	2012-10-19
CAZ RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	BD Spinal & Epidural Anesthesia Trays	2012-09-28
PMN K121087 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Next USB	2012-09-26
PMN K120568 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle InsulLinx Blood Glucose Meter	2012-09-26
PMN K120568 | NBW Kate Twomey [RR Donnelley - Global Turnkey Solutions]	InsuLinx	2012-09-26
PMN K120568 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle InsulLinx Blood Glucose Meter	2012-09-26
PMN K120568 | LFR Kate Twomey [RR Donnelley - Global Turnkey Solutions]	InsuLinx	2012-09-26
PMN K110894 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Next Link	2012-09-26
PMN K110894 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Next Link	2012-09-26
PMN K110894 | JJX RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Next Link	2012-09-26
PMN K110587 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Link	2012-09-26
PMN K110587 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour Link	2012-09-26
PMN K091820 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour USB	2012-09-26
PMN K091820 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour USB	2012-09-26
PMN K091820 | JQP RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour USB	2012-09-26
PMN K083223 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Relion Ultima Blood Glucose Monitoring System	2012-09-26
PMN K083223 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Relion Ultima Blood Glucose Monitoring System	2012-09-26
PMN K083223 | JJX RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Relion Ultima Blood Glucose Monitoring System	2012-09-26
PMN K081975 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Relion Ultima Advance Glucose Monitoring System	2012-09-26
PMN K081975 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Relion Ultima Advance Glucose Monitoring System	2012-09-26
PMN K081975 | JJX RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Relion Ultima Advance Glucose Monitoring System	2012-09-26
PMN K080960 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Precision Xceed Pro Glucose A&B	2012-09-26
PMN K080960 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Precision Xceed Pro Glucose A&B	2012-09-26
PMN K080960 | JIN RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Precision Xceed Pro Glucose A&B	2012-09-26
PMN K070984 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Precision Optium Point of Care Blood Glucose test	2012-09-26
PMN K070984 | NBW Kate Twomey [RR Donnelley - Global Turnkey Solutions]	Xceed H	2012-09-26
PMN K070984 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Precision Optium Point of Care Blood Glucose test	2012-09-26
PMN K070984 | LFR Kate Twomey [RR Donnelley - Global Turnkey Solutions]	Xceed H	2012-09-26
PMN K070850 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle Lite Blood Glucose Monitoring System	2012-09-26
PMN K062058 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour & Contour TS	2012-09-26
PMN K062058 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Contour & Contour TS	2012-09-26
PMN K051839 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle Freedom Blood Glucose Monitoring System	2012-09-26
PMN K051839 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle Freedom Blood Glucose Monitoring System	2012-09-26
PMN K051802 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle Connect Blood Glucose Monitoring System	2012-09-26
PMN K020866 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle Tracker Diabetes Management System	2012-09-26
PMN K000582 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle Blood Glucose Monitoring System	2012-09-26
PMN K000582 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	Freestyle Blood Glucose Monitoring System	2012-09-26
PMN K051213 | NBW RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	SOFT-TACT DIABETES	2005-09-19
PMN K051213 | LFR RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS	SOFT-TACT DIABETES	2005-09-19