Ascensia Diabetes Care US Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1810909	1810909	Ascensia Diabetes Care US Inc.	1	Y	2026-01-01	100 Summit Lake Drive Valhalla NY US 10595
3011121740	3010700165	Ascensia Diabetes Care US Inc.	1	Y	2026-01-01	5 Wood Hollow Road Parsippany NJ US 07054

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00301936020217	MICROLET® NEXT - Colored Lancets.	800-348-8100	support@contournext.com
00301936021214	MICROLET® NEXT - Colored Lancets.	800-348-8100	support@contournext.com
00301936260019	CONTOUR® NEXT LINK 2.4 - Wireless Blood Glucose Monitoring System. 1 Kit.For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.	18003488100	support@contournext.com
10301937080507	CONTOUR® - Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - RDC # 0193-7080-50).	18003488100	support@contournext.com
10301937277358	CONTOUR® NEXT - Blood Glucose Test strips. 35 test strips.	800-348-8100	support@contournext.com
10301937278706	CONTOUR® NEXT - Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total).	800-348-8100	support@contournext.com
40301936020215	MICROLET® NEXT - Colored Lancets.	800-348-8100	support@contournext.com
40301936021212	MICROLET® NEXT - Colored Lancets.	800-348-8100	support@contournext.com

contournext.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
191263	1534525097	P160017	MiniMed 670G System	OZP	2016-09-28
192848	1534525097	P160017	MiniMed 670G System	OZP	2016-09-28
192848	1492555049	P150001	MINIMED 630G SYSTEM WITH SMARTGUARD(TM)	OZO	2016-08-10
191263	1492555049	P150001	MINIMED 630G SYSTEM WITH SMARTGUARD(TM)	OZO	2016-08-10
192848	1056493549	K831600	DIASTIX REAGENT STRIPS FOR URINALYSIS	JIL	1983-09-08
191263	1056493549	K831600	DIASTIX REAGENT STRIPS FOR URINALYSIS	JIL	1983-09-08
192848	1337358993	K801270	TEST FOR KETONE IN URINE(ACETOACETIC AC	JIN	1980-07-08
191263	1337358993	K801270	TEST FOR KETONE IN URINE(ACETOACETIC AC	JIN	1980-07-08
191263	1247890607	K260545	CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System	NBW	2026-08-27
192848	1247890607	K260545	CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System	NBW	2026-08-27
191263	1998431943	K241810	MICROLET®NEXT Lancet	QRK	2024-08-15
192848	1998431943	K241810	MICROLET®NEXT Lancet	QRK	2024-08-15
191263	1724761781	K241787	CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System	NBW	2024-08-27
192848	1724761781	K241787	CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System	NBW	2024-08-27
192848	1129702752	K231679	CONTOUR® PLUS BLUE Blood Glucose Monitoring System	NBW	2024-02-23
191263	1129702752	K231679	CONTOUR® PLUS BLUE Blood Glucose Monitoring System	NBW	2024-02-23
191263	1147758777	K223293	CONTOUR® NEXT GEN Blood Glucose Monitoring System	NBW	2022-11-18
192848	1147758777	K223293	CONTOUR® NEXT GEN Blood Glucose Monitoring System	NBW	2022-11-18
192848	1067755245	K220633	MICROLET NEXT lancing device, MICROLET Lancet	QRL	2022-06-03
191263	1067755245	K220633	MICROLET NEXT lancing device, MICROLET Lancet	QRL	2022-06-03
192848	1214897858	K210687	CONTOUR® NEXT ONE Blood Glucose Monitoring System	NBW	2021-08-11
191263	1214897858	K210687	CONTOUR® NEXT ONE Blood Glucose Monitoring System	NBW	2021-08-11
192848	1598915488	K193407	Contour® next GEN Blood Glucose Monitoring System	NBW	2021-12-23
191263	1598915488	K193407	Contour® next GEN Blood Glucose Monitoring System	NBW	2021-12-23
191263	1950158680	K191286	CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System	NBW	2019-11-08
192848	1950158680	K191286	CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System	NBW	2019-11-08
192848	1958727235	K162336	Contour Next EZ Blood Glucose Monitoring System	NBW	2017-01-12
191263	1958727235	K162336	Contour Next EZ Blood Glucose Monitoring System	NBW	2017-01-12
191263	1302816265	K160682	CONTOUR NEXT ONE Blood Glucose Monitoring System	NBW	2016-11-17
192848	1302816265	K160682	CONTOUR NEXT ONE Blood Glucose Monitoring System	NBW	2016-11-17
192848	1446117500	K160430	Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System	NBW	2016-06-24
191263	1446117500	K160430	Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System	NBW	2016-06-24
192848	1700819276	K151742	Contour Next Control Solution	JJX	2015-09-23
191263	1700819276	K151742	Contour Next Control Solution	JJX	2015-09-23
192848	1211802849	K130265	CONTOUR NEXT EZ BLOOD GLUCOSE METER	NBW	2014-06-23
191263	1211802849	K130265	CONTOUR NEXT EZ BLOOD GLUCOSE METER	NBW	2014-06-23
192848	1416442507	K122370	CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR	NBW	2013-09-26
191263	1416442507	K122370	CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR	NBW	2013-09-26
191263	1924960678	K121190	CONTOUR NEXT BLOOD GLUCOSE METER	LFR	2012-07-26
192848	1924960678	K121190	CONTOUR NEXT BLOOD GLUCOSE METER	LFR	2012-07-26
192848	1031641593	K121087	CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM	NBW	2012-06-28
191263	1031641593	K121087	CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM	NBW	2012-06-28
192848	1047308950	K111268	CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM	LFR	2012-03-06
191263	1047308950	K111268	CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM	LFR	2012-03-06
191263	1709821602	K110894	CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER	LFR	2012-03-28
192848	1709821602	K110894	CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER	LFR	2012-03-28
191263	2042901743	K091820	CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM	NBW	2009-08-26
192848	2042901743	K091820	CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM	NBW	2009-08-26
191263	1020370375	K090628	DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080	NBW	2009-12-04
192848	1020370375	K090628	DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080	NBW	2009-12-04
192848	1376525541	K062058	ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080	NBW	2006-09-11
191263	1376525541	K062058	ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080	NBW	2006-09-11
192848	1445068292
191263	1445068292
192848	1088615311
191263	1088615311
191263	1190557141
192848	1190557141
191263	1243925699
192848	1243925699

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NBW	32	2026-08-27
LFR	6	2012-07-26
QRK	2	2024-08-15
QRL	2	2022-06-03
OZP	2	2016-09-28
OZO	2	2016-08-10
JJX	2	2015-09-23
JIL	2	1983-09-08
JIN	2	1980-07-08

PMN#

CONTOUR® NEXT GEN Blood Glucose Monitoring System
2022-11-18
Ascensia Diabetes Care US Inc.
Contour Next EZ Blood Glucose Monitoring System
2017-01-12
Ascensia Diabetes Care US Inc.
Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System
2016-06-24
Ascensia Diabetes Care US Inc.

GUDID#

CONTOUR® - Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - RDC # 0193-7080-50).
ASCENSIA DIABETES CARE US INC.
2016-09-16
CONTOUR® NEXT LINK 2.4 - Wireless Blood Glucose Monitoring System. 1 Kit.For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
ASCENSIA DIABETES CARE US INC.
2016-08-25
MICROLET® NEXT - Colored Lancets.
ASCENSIA DIABETES CARE US INC.
2026-03-16
MICROLET® NEXT - Colored Lancets.
ASCENSIA DIABETES CARE US INC.
2026-03-16
MICROLET® NEXT - Colored Lancets.
ASCENSIA DIABETES CARE US INC.
2026-03-16
MICROLET® NEXT - Colored Lancets.
ASCENSIA DIABETES CARE US INC.
2026-03-16
CONTOUR® NEXT - Blood Glucose Test strips. 35 test strips.
ASCENSIA DIABETES CARE US INC.
2017-11-03
CONTOUR® NEXT - Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total).
ASCENSIA DIABETES CARE US INC.
2017-11-03
CONTOUR® NEXT LINK 2.4 - Wireless Blood Glucose Monitoring System. 1 Kit.For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
ASCENSIA DIABETES CARE US INC.
2016-08-25
CONTOUR® NEXT GEN - """Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.Kit contains: CONTOUR® NEXT GEN blood glucose meter, Lancing Device, 10 CONTOUR® NEXT blood glucose test strips, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, Web Registration/Warranty Card, CONTOUR® NEXT control solution"""
ASCENSIA DIABETES CARE US INC.
2022-06-30
CONTOUR® PLUS BLUE - """For self - testing, monitoring, and management of blood glucose.Kit contains:-Contour Plus Blue blood glucose meter (Product of Indonesia)-10 Contour Plus blood glucose test strips (Product of Japan)-Microlet Next lancing device (Product of Poland)-10 Microlet lancets (Product of Poland)-User Guide-Quick Reference Guide-Carrying Case (Product of China)"""
ASCENSIA DIABETES CARE US INC.
2025-01-06
CONTOUR® NEXT - Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
2016-08-25
CONTOUR® NEXT - Blood Glucose Test Strips - 25 Test Strips.
ASCENSIA DIABETES CARE US INC.
2016-08-25
CONTOUR® NEXT - Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
2016-08-25
CONTOUR® NEXT - Blood Glucose Test Strips - 50 Test Strips (per bottle) - sold in a carton of 2 bottles (100 test strips total).
ASCENSIA DIABETES CARE US INC.
2016-08-25
CONTOUR® NEXT - Control Solution - Level 2. 1 x 2.5 mL.
ASCENSIA DIABETES CARE US INC.
2016-09-16
CONTOUR® NEXT - Control Solution - Level 1. 1 x 2.5 mL.
ASCENSIA DIABETES CARE US INC.
2016-09-16
CONTOUR®NEXT - Blood glucose test strips. Sold in a carton of 15 test strips.
ASCENSIA DIABETES CARE US INC.
2019-08-30
CONTOUR® PLUS BLUE - """Contour Plus BlueBlood Glucose monitoring SystemFor Self- testing, mornitoring and management of blood glucose.Kit Contains:-Contour Plus Blue blood glucose meter (product of Indonesia)-Micolet Next Lancing device (Product of Poland) -User Guide-Quick Reference Guide- Carrying Case (Product of China)Control solutions are required but not included and must be purchased separately"""
ASCENSIA DIABETES CARE US INC.
2024-08-01
CONTOUR® NEXT GEN - """For self-testing, monitoring, and management of blood glucose.Kit contains: CONTOUR® NEXT GEN blood glucose meter, 20 CONTOUR® NEXT blood glucose test strips, Lancing Device, 20 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, Web Registration/Warranty Card"""
ASCENSIA DIABETES CARE US INC.
2022-06-30
CONTOUR® PLUS - Blood Glucose Test Strips. 50 test strips.
ASCENSIA DIABETES CARE US INC.
2024-08-01
CONTOUR® PLUS - Control Solution - Level 1. 1 x 2.5 mL.
ASCENSIA DIABETES CARE US INC.
2024-08-01
CONTOUR® PLUS - Control Solution - Level 2. 1 x 2.5 mL.
ASCENSIA DIABETES CARE US INC.
2024-08-01
CONTOUR® NEXT GEN - """For self-testing, monitoring, and management of blood glucose.Kit contains: CONTOUR® NEXT GEN blood glucose meter, Lancing Device, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case"""
ASCENSIA DIABETES CARE US INC.
2023-07-21
CONTOUR® PLUS - For Self-TestingFor use with the CONTOUR® Plus BLUE meter
ASCENSIA DIABETES CARE US INC.
2024-05-30
CONTOUR® NEXT GEN - """For self-testing, monitoring, and management of blood glucose.Kit contains: CONTOUR® NEXT GEN blood glucose meter, 10 CONTOUR® NEXT blood glucose test strips, Lancing Device, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case"""
ASCENSIA DIABETES CARE US INC.
2025-01-20
CONTOUR® PLUS BLUE - """For self - testing, monitoring, and management of blood glucose.Kit contains:-Contour Plus Blue blood glucose meter (Product of Indonesia)-10 Contour Plus blood glucose test strips (Product of Japan)-Microlet Next lancing device (Product of Poland)-10 Microlet lancets (Product of Poland)-User Guide-Quick Reference Guide-Carrying Case (Product of China)Contour Plus control solution (Product of USA)"""
ASCENSIA DIABETES CARE US INC.
2024-05-30
CONTOUR® NEXT GEN - Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.Kit contains: CONTOUR® NEXT GEN blood glucose meter, Lancing Device, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, Web Registration/Warranty Card.
ASCENSIA DIABETES CARE US INC.
2022-07-01
CONTOUR® DIABETES APP - Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
2022-02-18
CONTOUR® DIABETES APP - Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
2022-02-18
CONTOUR® NEXT - Blood Glucose Test Strips - 10 Test Strips.
ASCENSIA DIABETES CARE US INC.
2016-08-25
CONTOUR® NEXT - Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of diabetes.This kit contains the following items: CONTOUR® Next Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case; CONTOUR® NEXT Control Solution; Warranty Card.
ASCENSIA DIABETES CARE US INC.
2016-09-16
CONTOUR® NEXT EZ - Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.This kit contains the following items: CONTOUR® Next EZ Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case.
ASCENSIA DIABETES CARE US INC.
2016-09-16
CONTOUR® NEXT ONE - Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution.
ASCENSIA DIABETES CARE US INC.
2016-12-16
GLUCOFACTS® DELUXE - Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
2016-09-16
CONTOUR® NEXT - Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.In this kit you will find: CONTOUR® NEXT Blood Glucose Meter; User Guide and Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook and Carrying Case; Warranty Card.
ASCENSIA DIABETES CARE US INC.
2016-09-16
CONTOUR® NEXT - Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.In this kit you will find: CONTOUR® NEXT Blood Glucose Meter; 20 CONTOUR® NEXT Blood Glucose Test Strips; User Guide and Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook and Carrying Case; Warranty Card.
ASCENSIA DIABETES CARE US INC.
2016-09-16
CONTOUR® NEXT GEN - "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, 10 CONTOUR® NEXT blood glucose test strips, Lancing Device, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case"
ASCENSIA DIABETES CARE US INC.
2025-01-20
CONTOUR® NEXT GEN - """For self-testing, monitoring, and management of blood glucose.Kit contains: CONTOUR® NEXT GEN blood glucose meter, 10 CONTOUR® NEXT blood glucose test strips, Lancing Device, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, CONTOUR® NEXT control solution"""
ASCENSIA DIABETES CARE US INC.
2023-07-21
CONTOUR® NEXT EZ - Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.This kit contains the following items: CONTOUR® Next EZ Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case.
ASCENSIA DIABETES CARE US INC.
2025-01-06

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