FDA.reportPublic FDA data

Ascensia Diabetes Care US Inc.

Matched from indexed company URL: ASCENSIA DIABETES CARE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18109091810909Ascensia Diabetes Care US Inc.1N2026-01-01100 Summit Lake Drive Valhalla NY US 10595
30111217403010700165Ascensia Diabetes Care US Inc.1N2026-01-015 Wood Hollow Road Parsippany NJ US 07054
30121186593012118659ASCENSIA DIABETES CARE HOLDINGS AG1N2026-01-01Peter Merian-Strasse 90 Basel Basel-Stadt CH CH-4052

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 GUDIDProductPhoneEmail
00301936020217MICROLET® NEXT - Colored Lancets.800-348-8100support@contournext.com
00301936021214MICROLET® NEXT - Colored Lancets.800-348-8100support@contournext.com
00301936260019CONTOUR® 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.18003488100support@contournext.com
10301937080507CONTOUR® - Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - RDC # 0193-7080-50).18003488100support@contournext.com
10301937277358CONTOUR® NEXT - Blood Glucose Test strips. 35 test strips.800-348-8100support@contournext.com
10301937278706CONTOUR® NEXT - Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total).800-348-8100support@contournext.com
40301936020215MICROLET® NEXT - Colored Lancets.800-348-8100support@contournext.com
40301936021212MICROLET® NEXT - Colored Lancets.800-348-8100support@contournext.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1928481534525097P160017MiniMed 670G SystemOZP2016-09-28
1912631534525097P160017MiniMed 670G SystemOZP2016-09-28
2544691534525097P160017MiniMed 670G SystemOZP2016-09-28
1912631492555049P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)OZO2016-08-10
1928481492555049P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)OZO2016-08-10
2544691492555049P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)OZO2016-08-10
1928481056493549K831600DIASTIX REAGENT STRIPS FOR URINALYSISJIL1983-09-08
2544691056493549K831600DIASTIX REAGENT STRIPS FOR URINALYSISJIL1983-09-08
1912631056493549K831600DIASTIX REAGENT STRIPS FOR URINALYSISJIL1983-09-08
1928481337358993K801270TEST FOR KETONE IN URINE(ACETOACETIC ACJIN1980-07-08
2544691337358993K801270TEST FOR KETONE IN URINE(ACETOACETIC ACJIN1980-07-08
1912631337358993K801270TEST FOR KETONE IN URINE(ACETOACETIC ACJIN1980-07-08
2544691998431943K241810MICROLET®NEXT LancetQRK2024-08-15
1912631998431943K241810MICROLET®NEXT LancetQRK2024-08-15
1928481998431943K241810MICROLET®NEXT LancetQRK2024-08-15
2544691724761781K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2024-08-27
1912631724761781K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2024-08-27
1928481724761781K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2024-08-27
2544691129702752K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW2024-02-23
1912631129702752K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW2024-02-23
1928481129702752K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW2024-02-23
1928481147758777K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2022-11-18
1912631147758777K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2022-11-18
2544691147758777K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2022-11-18
1928481067755245K220633MICROLET NEXT lancing device, MICROLET LancetQRL2022-06-03
2544691067755245K220633MICROLET NEXT lancing device, MICROLET LancetQRL2022-06-03
1912631067755245K220633MICROLET NEXT lancing device, MICROLET LancetQRL2022-06-03
1928481214897858K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemNBW2021-08-11
2544691214897858K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemNBW2021-08-11
1912631214897858K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemNBW2021-08-11
1928481598915488K193407Contour® next GEN Blood Glucose Monitoring SystemNBW2021-12-23
1912631598915488K193407Contour® next GEN Blood Glucose Monitoring SystemNBW2021-12-23
2544691598915488K193407Contour® next GEN Blood Glucose Monitoring SystemNBW2021-12-23
1928481950158680K191286CONTOUR® 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 SystemNBW2019-11-08
2544691950158680K191286CONTOUR® 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 SystemNBW2019-11-08
1912631950158680K191286CONTOUR® 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 SystemNBW2019-11-08
1928481958727235K162336Contour Next EZ Blood Glucose Monitoring SystemNBW2017-01-12
1912631958727235K162336Contour Next EZ Blood Glucose Monitoring SystemNBW2017-01-12
2544691958727235K162336Contour Next EZ Blood Glucose Monitoring SystemNBW2017-01-12
2544691302816265K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemNBW2016-11-17
1928481302816265K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemNBW2016-11-17
1912631302816265K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemNBW2016-11-17
1912631446117500K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring SystemNBW2016-06-24
2544691446117500K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring SystemNBW2016-06-24
1928481446117500K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring SystemNBW2016-06-24
1912631700819276K151742Contour Next Control SolutionJJX2015-09-23
1928481700819276K151742Contour Next Control SolutionJJX2015-09-23
2544691700819276K151742Contour Next Control SolutionJJX2015-09-23
1912631211802849K130265CONTOUR NEXT EZ BLOOD GLUCOSE METERNBW2014-06-23
1928481211802849K130265CONTOUR NEXT EZ BLOOD GLUCOSE METERNBW2014-06-23
2544691211802849K130265CONTOUR NEXT EZ BLOOD GLUCOSE METERNBW2014-06-23
1928481416442507K122370CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITORNBW2013-09-26
1912631416442507K122370CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITORNBW2013-09-26
2544691416442507K122370CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITORNBW2013-09-26
2544691924960678K121190CONTOUR NEXT BLOOD GLUCOSE METERLFR2012-07-26
1928481924960678K121190CONTOUR NEXT BLOOD GLUCOSE METERLFR2012-07-26
1912631924960678K121190CONTOUR NEXT BLOOD GLUCOSE METERLFR2012-07-26
1912631031641593K121087CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEMNBW2012-06-28
2544691031641593K121087CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEMNBW2012-06-28
1928481031641593K121087CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEMNBW2012-06-28
2544691047308950K111268CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEMLFR2012-03-06
1928481047308950K111268CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEMLFR2012-03-06
1912631047308950K111268CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEMLFR2012-03-06
1928481709821602K110894CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METERLFR2012-03-28
2544691709821602K110894CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METERLFR2012-03-28
1912631709821602K110894CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METERLFR2012-03-28
1912632042901743K091820CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEMNBW2009-08-26
1928482042901743K091820CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEMNBW2009-08-26
2544692042901743K091820CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEMNBW2009-08-26
2544691020370375K090628DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080NBW2009-12-04
1912631020370375K090628DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080NBW2009-12-04
1928481020370375K090628DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080NBW2009-12-04
2544691376525541K062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080NBW2006-09-11
1928481376525541K062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080NBW2006-09-11
1912631376525541K062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080NBW2006-09-11
1912631445068292
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2544691445068292
1928481088615311
2544691088615311
1912631088615311
1928481190557141
1912631190557141
2544691190557141
1928481243925699
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Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW452024-08-27
LFR92012-07-26
QRK32024-08-15
QRL32022-06-03
OZP32016-09-28
OZO32016-08-10
JJX32015-09-23
JIL31983-09-08
JIN31980-07-08

PMN#

GUDID#

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