| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00883489001276 | GE100 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | GE | |||
| 2 | 00883489001399 | GE100 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | GE | |||
| 3 | 00883489001658 | 333 | NBW | System, Test, Blood Glucose, Over The Counter | GE | |||
| 4 | 00883489001139 | GM550 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | Rightest | ||
| 5 | 00883489001351 | GE100 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | GE | |||
| 6 | 00883489001337 | GE100 Control Solution | JJX,NBW | Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | GE | ||
| 7 | 00883489001252 | GE100 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | GE | |||
| 8 | 00883489001238 | GE100 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | GE | |||
| 9 | 00883489001214 | GE100 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | GE | |||
| 10 | 00883489001191 | GE100 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | GE | ||
| 11 | 00883489001818 | GE333 | GE333 control solution (High level) | JJX,NBW | Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | GE | ||
| 12 | 00883489001795 | GE333 | GE333 control solution(Normal Level) | NBW,JJX | System, Test, Blood Glucose, Over The Counter,Single (Specified) Analyte Control System, Test, Blood Glucose, Over The Counter,Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GE | |
| 13 | 00883489001726 | Max Plus | 1 meter -008834890017191 vial of 10 pcs strip -008834890017571 lancing device - 1 meter -008834890017191 vial of 10 pcs strip -008834890017571 lancing device -008834890017711 control solution -008834890017881 pack of 10 pcs lancet -00883489001764 | NBW | System, Test, Blood Glucose, Over The Counter | 2 | GE | |
| 14 | 00883489001719 | Max Plus | meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | GE | |
| 15 | 00883489001696 | 333 | NBW | System, Test, Blood Glucose, Over The Counter | GE | |||
| 16 | 00883489001672 | 333 | strip vial | NBW | System, Test, Blood Glucose, Over The Counter | GE | ||
| 17 | 00883489001177 | GE100 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GE | |||
| 18 | 00883489001153 | GS550 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Rightest | |||
| 19 | 00883489001078 | GS100 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Rightest | |||
| 20 | 00883489001634 | 333 | meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | GE | |
| 21 | 00883489001603 | GC300 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Rightest | ||
| 22 | 00883489310309 | GE100 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GE | |||
| 23 | 00883489310293 | GM250 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Rightest | ||
| 24 | 00883489001375 | GS550 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | GE | |||
| 25 | 00883489001498 | GS100 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Rightest | |||
| 26 | 00883489001450 | GP200 | JQP,NBW | Calculator/Data Processing Module, For Clinical Use,System, Test, Blood Glucose, Calculator/Data Processing Module, For Clinical Use,System, Test, Blood Glucose, Over The Counter | 1 | Rightest | ||
| 27 | 00883489001443 | GE100 Control Solution | NBW,JJX | System, Test, Blood Glucose, Over The Counter,Single (Specified) Analyte Control System, Test, Blood Glucose, Over The Counter,Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GE | ||
| 28 | 00883489001436 | GE100 Control Solution | NBW,JJX | System, Test, Blood Glucose, Over The Counter,Single (Specified) Analyte Control System, Test, Blood Glucose, Over The Counter,Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GE | ||
| 29 | 00883489001412 | GS100 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Rightest | |||
| 30 | 00883489001405 | GS300 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Rightest | |||
| 31 | 00883489001054 | GM100 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | Rightest | ||
| 32 | 00883489001047 | GC300 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Rightest | ||
| 33 | 00883489001023 | GS300 | 99GS300115 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Rightest | ||
| 34 | 00883489001009 | GM300 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Rightest | |||
| 35 | 00883489000873 | GP200 | JQP,NBW | Calculator/Data Processing Module, For Clinical Use,System, Test, Blood Glucose, Calculator/Data Processing Module, For Clinical Use,System, Test, Blood Glucose, Over The Counter | 1 | GE | ||
| 36 | 10883489310436 | 333 | one box contained 2 meter kitbox and 8 50pcs-strip box. | NBW | System, Test, Blood Glucose, Over The Counter | 2 | GE | |
| 37 | 10883489084849 | GE100 | 99GM555CZ1 | The combination products includes 2 boxes(00883489001207) of meters(008834890011 The combination products includes 2 boxes(00883489001207) of meters(00883489001191) and 8 boxes(00883489001245) of strips(00883489001238) | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | GE |
| 38 | 00883489002037 | GS700 | 25 pcs strips(80883489002033) per vial, 2 vials(00883489002037) per box | NBW | System, Test, Blood Glucose, Over The Counter | RIGHTEST | ||
| 39 | 00883489001900 | 100PCS | NBW | System, Test, Blood Glucose, Over The Counter | RIGHTEST GT333 Blood Glucose Test Strip | |||
| 40 | 00883489001887 | 50 PCS | NBW | System, Test, Blood Glucose, Over The Counter | RIGHTEST GT333 Blood Glucose Test Strip | |||
| 41 | 00883489001863 | 25pcs | NBW | System, Test, Blood Glucose, Over The Counter | RIGHTEST GT333 Blood Glucose Test Strip | |||
| 42 | 00883489001733 | Max Strip | One box with 2 vials strip | NBW | System, Test, Blood Glucose, Over The Counter | GE | ||
| 43 | 00883489001849 | Meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | RIGHTEST GT333 Blood Glucose Monitoring System | ||
| 44 | 00883489001542 | iGlucose test strips | 99GS291I51 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | ODM | ||
| 45 | 00883489002419 | Diathrive+ Blood Glucose Test Strip | 99GS280D51 | 25 strips - 80883489002415 | NBW | System, Test, Blood Glucose, Over The Counter | ODM | |
| 46 | 00883489002396 | Diathrive+ Bluetooth Blood Glucose Monitoring System | 99GM282DR1 | 1 meter - 00883489002396 | NBW | System, Test, Blood Glucose, Over The Counter | ODM | |
| 47 | 00883489002372 | Diathrive+ Blood Glucose Monitoring System | 99GM280DR1 | 1 meter - 00883489002372 | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ODM |
| 48 | 00883489001924 | Level 2 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | RIGHTEST GT333 Control Solution | ||
| 49 | 00883489001504 | iGlucose Blood Glucose Monitoring System | 99GM291I01 | The combination products includes 1 pce of lancing device_GD500(00883489001566), The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control solution(00883489001580),10 pcs/set of lancet(Sterile)(00883489001597) and 10 pcs/vial of strips_iGlucose Strip(00883489001573). | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | ODM |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00854427007148 | KIT - Glucose Monitoring System | Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lan Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lancets, 1 logbook, 1 user manual | HEPRO.US MM1000 Blood Glucose Monitoring System Kit | HEPRO.US INC. | |
| 2 | 00854067005238 | EHS-SDMK-V | Smart Diabetes Voice Glucose Monitor | Smart Diabetes | VALUE PROVIDERS LLC | |
| 3 | 00854067005191 | EHS-SDMK-BT | Smart Diabetes Bluetooth Glucose Monitor | Eocene | VALUE PROVIDERS LLC | |
| 4 | 00853553005417 | Livongo | KIT01595 | Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish) | Livongo Replacement Device | LIVONGO HEALTH, INC |
| 5 | 00853553005400 | Livongo | KIT01594 | BG300, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box BG300, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish) | Livongo Welcome Kit | LIVONGO HEALTH, INC |
| 6 | 00853553005349 | BG300 | FG02062 | Blood Glucose Meter BG300C | Livongo Blood Glucose Meter | LIVONGO HEALTH, INC |
| 7 | 00853553005318 | Livongo G2.0FW2.1 | KIT00803 | BG300, 1 vial of Livongo Test strips, 1 bag of Livongo Sterile Lancets, 1 box o BG300, 1 vial of Livongo Test strips, 1 bag of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish) | Livongo Demo Kit | LIVONGO HEALTH, INC |
| 8 | 00853553005301 | Livongo G2.0FW2.1 | KIT00802 | BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish) | Livongo Replacement Device | LIVONGO HEALTH, INC |
| 9 | 00853553005295 | Livongo G2.0FW2.1 | KIT00801 | BG300, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box BG300, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish) | Livongo Welcome Kit | LIVONGO HEALTH, INC |
| 10 | 00853553005288 | BG300 | FG00688 | Livongo BG300 Blood Glucose Meter | Livongo Blood Glucose Meter | LIVONGO HEALTH, INC |
| 11 | 00853553005271 | Livongo | KIT00425 | Livongo Demo Kit with BG300, 1 vial of Livongo Test strips, 1 bag of Livongo St Livongo Demo Kit with BG300, 1 vial of Livongo Test strips, 1 bag of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Livongo Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish) | Livongo Demo Kit | LIVONGO HEALTH, INC |
| 12 | 00853553005257 | Livongo G1.5 | KIT00441 | Livongo Welcome Kit G1.5 with BG200, 3 vials of Livongo Test strips, 4 bags of L Livongo Welcome Kit G1.5 with BG200, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Livongo Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish) | Livongo Welcome Kit | LIVONGO HEALTH, INC |
| 13 | 00853553005240 | Livongo | KIT00423 | Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish) | Livongo Replacement Device | LIVONGO HEALTH, INC |
| 14 | 00853553005233 | Livongo G2.0 | KIT00421 | Livongo Welcome Kit G2.0 with BG300, 3 vials of Livongo Test strips, 4 bags of L Livongo Welcome Kit G2.0 with BG300, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low,1 Livongo Lancing device, 1 Livongo Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish) | Livongo Welcome Kit | LIVONGO HEALTH, INC |
| 15 | 00853553005196 | BG300 | FG00408 | Livongo BG300 Blood Glucose Meter | Livongo Blood Glucose Meter | LIVONGO HEALTH, INC |
| 16 | 00853553005097 | In Touch | KIT00145 | In Touch Blood Glucose Meter BG200, 1 In Touch Control Solution high/low, 3 boxe In Touch Blood Glucose Meter BG200, 1 In Touch Control Solution high/low, 3 boxes of In Touch Test Strips, 1 In Touch Lancing Device, 3 boxes of sterile In Touch Lancets, 1 Carrying Case, 1 Charger, 1 Charger cable, 1 Instructions for Use (English and Spanish), About Guide (English and Spanish) | In Touch Welcome Kit | LIVONGO HEALTH, INC |
| 17 | 00853553005035 | BG200 | FG00163 | In Touch BG 200 Blood Glucose Meter with Charger Adapter and USB Cable | In Touch Blood Glucose Meter | LIVONGO HEALTH, INC |
| 18 | 00853553005011 | BG300C, Kaifa DongGuan | FG02062 | BG300 rev C Blood Glucose Meter, Kaifa DongGuan | Livongo Blood Glucose Meter | LIVONGO HEALTH, INC |
| 19 | 00853483008243 | VGM04 | VivaGuard Ino Smart Blood Glucose Meter | VivaGuard Ino Smart | ABLE DIAGNOSTICS INC | |
| 20 | 00853483008236 | VGM04 | VGM04-665 | VivaGuard Ino Smart Blood Glucose Meter Only Kit | VivaGuard Ino Smart | ABLE DIAGNOSTICS INC |
| 21 | 00853483008151 | VGM01 | VivaGuard Ino Blood Glucose Meter | VivaGuard Ino | ABLE DIAGNOSTICS INC | |
| 22 | 00853483008052 | VGM01 | VGM01-373 | VivaGuard Ino Blood Glucose Meter Only Kit | VivaGuard Ino | ABLE DIAGNOSTICS INC |
| 23 | 00853483008007 | VGM01 | VGM01-371 | VivaGuard Ino Blood Glucose Monitoring System | VivaGuard Ino | ABLE DIAGNOSTICS INC |
| 24 | 00852982006491 | BMB002-10 | BMB002-10 | Advocate Redi-Code+ Test Strips for Blood Glucose 10 count | Advocate Redi-Code+ Test Strips for Blood Glucose 10 count | DIABETIC SUPPLY OF SUNCOAST, INC. |
| 25 | 00852668007095 | MGH-BT1 | Blood Glucose meter (label) | MyGlucoHealth® BT Meter | ENTRA HEALTH SYSTEMS LLC | |
| 26 | 00852668007071 | BLE-SMART-METER | Blood Glucose Meter Label | BLE Smart® Blood Glucose Meter | ENTRA HEALTH SYSTEMS LLC | |
| 27 | 00852668007064 | BLE-SMART-METER-FDA | Blood Glucose Meter Kit | BLE Smart® Blood Glucose System | ENTRA HEALTH SYSTEMS LLC | |
| 28 | 00852668007057 | MGH-CL1 | Wireless Blood Glucose Meter | MyGlucoHealth® Wireless Blood Glucose Meter | ENTRA HEALTH SYSTEMS LLC | |
| 29 | 00852668007040 | MGH-CL1 | Wireless Blood Glucose Meter Kit | MyGlucoHealth® Wireless Blood Glucose System | ENTRA HEALTH SYSTEMS LLC | |
| 30 | 00851225008001 | 300300 | LucidPlus B-Ketone Plus Blood Glucose Monitoring System | VIDAN DIAGNOSTICS LLC | ||
| 31 | 00850632007386 | 1 | Easy Trak II Control Solution High for use with Easy Trak II strips in the Easy Easy Trak II Control Solution High for use with Easy Trak II strips in the Easy Trak II meter. For use only within 90 days of opening.Do not use after expiration date. | Easy Trak II Control Solution High | HOME AIDE DIAGNOSTICS, INC. | |
| 32 | 00850632007379 | 1 | Easy Trak II Blood Glucose Test Strips for use with Easy Trak II meter only. Sin Easy Trak II Blood Glucose Test Strips for use with Easy Trak II meter only. Single use strips. 2 bottles of 25 strips in one 50 strip box. | Easy Trak II Glucose Test Strips 25 count | HOME AIDE DIAGNOSTICS, INC. | |
| 33 | 00850632007362 | 1 | Blood Glucose Monitor for use with Easy Trak II Testing Strips only | Easy Trak II Blood Glucose Meter | HOME AIDE DIAGNOSTICS, INC. | |
| 34 | 00850578007396 | CT Glucosemeter kits | Case/Carton of 40 boxes of ONE GLUCOSEMETER KIT HEPRO.US MM1000 Copy | HEPRO.US MM1000 BRAND CT40 GLUCOSEMETER KIT - | HEPRO.US INC. | |
| 35 | 00850578007044 | GLUCOSE TEST STRIP 50 CT. | HEPRO.US GLUCOSE TEST STRIPS 50units/BX for MM1000 | GLUCOSE TEST STRIP 50 CT. | HEPRO.US INC. | |
| 36 | 00850081003007 | MGH-BT1 | Blood Glucose Meter Kit | MyGlucoHealth® BT Meter Kit | ENTRA HEALTH SYSTEMS LLC | |
| 37 | 00850065006505 | 1193-05 | The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood g The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario USB-C meter is connected to a SMD connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario USB-C blood glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform.Dario USB-C Blood Glucose Monitoring System & Dario Membership includes 50 Dario Blood Glucose Test Strips. Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. | Dario USB-C Blood Glucose Monitoring System & Dario Membership | LABSTYLE INNOVATION LTD | |
| 38 | 00850065006451 | 1183-05 | The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood gluc The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The DarioLC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display forthe user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. Dario LC Blood Glucose Monitoring System & Dario Membership includes 50 Dario Blood Glucose Test Strips. Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. | Dario LC Blood Glucose Monitoring System & Dario Membership | LABSTYLE INNOVATION LTD | |
| 39 | 00850065006444 | 1173-05 | The Dario Blood Glucose Monitoring System is a compact, all-in-one blood glucose The Dario Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dariometer is connected to a SMD connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario blood glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform.Dario Blood Glucose Monitoring System & Dario Membership includes 50 Dario Blood Glucose Test Strips. Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. | Dario Blood Glucose Monitoring System & Dario Membership | LABSTYLE INNOVATION LTD | |
| 40 | 00850065006406 | 1200-05 | The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood g The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The DarioUSB-C meter is connected to a SMD through a USB-C connector in order to provide the glucose meter with power. The SMD also provides an external display forthe user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario USB-C glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. (DI# 00850065006390)The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.(DI#00850065006178) | Dario® USB-C Blood Glucose Monitoring System - Starter Kit | LABSTYLE INNOVATION LTD | |
| 41 | 00850065006390 | 1152-05 | The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood g The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The DarioUSB-C meter is connected to a SMD through USB-C connector in order to provide the glucose meter with power. The SMD also provides an external display forthe user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario USB-C glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. | Dario® USB-C Blood Glucose Monitoring System | LABSTYLE INNOVATION LTD | |
| 42 | 00850065006253 | 1147-05 | The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood gluc The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The DarioLC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display forthe user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. (DI# 00850065006154)The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.(DI#00850065006178) | Dario LC Starter Kit | LABSTYLE INNOVATION LTD | |
| 43 | 00850065006246 | 1146-05 | The Dario Blood Glucose Monitoring System is a compact, all-in-one blood glucose The Dario Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dariometer is connected to a SMD connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario blood glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. (DI# 00850065006000)The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.(DI#00850065006178) | Dario Starter Kit | LABSTYLE INNOVATION LTD | |
| 44 | 00850065006161 | 1015-05 | The Dario Blood Glucose Monitoring System is intended for self-testing outside t The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. | Dario Blood Glucose Monitoring System | LABSTYLE INNOVATION LTD | |
| 45 | 00850065006154 | 1138-05 | The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood gluc The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The DarioLC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display forthe user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. | Dario LC Blood Glucose Monitoring System | LABSTYLE INNOVATION LTD | |
| 46 | 00850042929049 | HH-XIII-T | TeleBGM Lancing Device | Mio Lancing Device | MIO | MIO LABS INC. |
| 47 | 00850042929032 | I | Mio Single Use Lancets | MIO | MIO LABS INC. | |
| 48 | 00850042929025 | VGC01 | TeleBGM Control Solution | Mio Control Solution | MIO | MIO LABS INC. |
| 49 | 00850042929018 | VGS01 | TeleBGM Test Strip | Blood Glucose Test Strip | MIO | MIO LABS INC. |
| 50 | 00850042929001 | VGM04 | TeleBGM Gen-1(BLE) | Blood Glucose Meter | MIO | MIO LABS INC. |