Product Code: NBW


Products Classified as NBW

630System, Test, Blood Glucose, Over The CounterGlucose Test System.

Total Product Life Cycle (TPLC) Devices

630System, Test, Blood Glucose, Over The CounterGlucose Test System.

FDA Consensus Standards

System, Test, Blood Glucose, Over The Counter [32368]21 CFR §862.1345 šŸ”Ž
System, Test, Blood Glucose, Over The Counter [35909]21 CFR §862.1345 šŸ”Ž
System, Test, Blood Glucose, Over The Counter [35812]21 CFR §862.1345 šŸ”Ž

Pre-market Notifications for NBW

K200277Livongo Blood Glucose Monitoring System (BG1000)Livongo Health, Inc.
K193590CareSens S Fit BT Blood Glucose Monitoring SystemI-SENS, Inc.
K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemLifeScan Europe GmbH
K192859CareSens S Clear BT Blood Glucose Monitoring SystemI-SENS, Inc.
K192220ReliOn Premier Classic Blood Glucose Monitoring SystemI-SENS, Inc.
K192175On Call Express II Blood Glucose Monitoring SystemACON Laboratories, Inc.
K191657Bioland Blood Glucose Monitoring SystemBioland Technology Ltd.
K191286CONTOURĀ® NEXT Blood Glucose Monitoring System, CONTOURĀ® NEXT USB Blood Glucose Monitoring System, CONTOURĀ® NEXT ONE Blood Glucose Monitoring System, CONTOURĀ® NEXT EZ Blood Glucose Monitoring System, CONTOURĀ® NEXT LINK Wireless Blood Glucose MonitorinAscensia Diabetes Care
K191038On Call Express Voice Blood Glucose Monitoring SystemACON Laboratories, Inc.
K190579TD-4183 Blood Glucose Monitoring SystemTaiDoc Technology Corporation
K190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SBBionime Corporation
K190189MDT2 BLE Self-Monitoring Blood Glucose SystemEPS Bio Technology Corp.
K183306GLUCOCARDĀ® W Onyx Blood Glucose Monitoring SystemARKRAY Factory, Inc.
K182992BGM014 Blood Glucose Monitoring SystemApex Biotechnology Corp.
K182428GlucoLeader Enhance Blood Glucose Monitoring SystemHMD BioMedical Inc.

Global Unique Device Identification Database

10605388860160SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
10605388860153SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
10605388492286SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
10605388022933SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
10605388022926SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
00389167348508System, Test, Blood Glucose, Over The Counter
00389154000709System, Test, Blood Glucose, Over The Counter
20385544940017System, Test, Blood Glucose, Over The Counter
00385544025017System, Test, Blood Glucose, Over The Counter
20385542649011System, Test, Blood Glucose, Over The Counter
10385541002605System, Test, Blood Glucose, Over The Counter
00385541002509System, Test, Blood Glucose, Over The Counter
10385541002407System, Test, Blood Glucose, Over The Counter
10385541002001System, Test, Blood Glucose, Over The Counter
20385541000806System, Test, Blood Glucose, Over The Counter

Maude Adverse Events

TRUE METRIXTRIVIDIA HEALTH INC2020-03-31
TRUE METRIXTRIVIDIA HEALTH INC2020-03-31
TRUE METRIXTRIVIDIA HEALTH INC2020-03-31
TRUE METRIXTRIVIDIA HEALTH INC2020-03-31
TRUE METRIXTRIVIDIA HEALTH INC2020-03-31
TRUE METRIXTRIVIDIA HEALTH INC2020-03-31
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? SMARTVIEW TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? PERFORMA COMBOROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? PERFORMA COMBOROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? PERFORMA COMBOROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? PERFORMA COMBOROCHE DIABETES CARE, INC.2020-03-31
OT VERIO IQ METERLIFESCAN EUROPE GMBH2020-03-31
OT VERIO IQ METERLIFESCAN EUROPE GMBH2020-03-31
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA COMBOROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA COMBOROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
PRODIGY AUTO CODEOK BIOTECH COMPANY LTD2020-03-31
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-30
ACCU-CHEK ? PERFORMA COMBOROCHE DIABETES CARE, INC.2020-03-30
ACCU-CHEK ? AVIVA COMBOROCHE DIABETES CARE, INC.2020-03-30
ACCU-CHEK ? AVIVA EXPERTROCHE DIABETES CARE, INC.2020-03-30
ACCU-CHEK ? NANOROCHE DIABETES CARE, INC.2020-03-30
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-30
OT VERIO FLEX METERLIFESCAN EUROPE GMBH2020-03-30
OT VERIO FLEX METERLIFESCAN EUROPE GMBH2020-03-30
PRODIGY AUTO CODEOK BIOTECH COMPANY LTD2020-03-29
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? SMARTVIEW TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28

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