| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00894030002697 | APX02AB0511 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Control Solution Hi | ||
| 2 | 00894030002666 | APX01AB0500VK | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Value Kit (50ct Included) | ||
| 3 | 00894030002543 | APX01AGS0100-SR | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials) | ||
| 4 | 00894030002536 | APX01AK0200VK | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Meter Value Pack (incl. 50ct) | ||
| 5 | 00894030002376 | APX02AB0811 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace EVO Control Solution, L2 (Medium) | ||
| 6 | 00894030002482 | APX01GS0100-L | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | EmbraceEVO Gestational Diabetes Package - LARGE (9 vials) | ||
| 7 | 00894030002017 | APX01AB200 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Meter, Meter Only | ||
| 8 | 00894030002581 | APX02GS0202RF | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Gestational Diabetes Package - RETAIL (5 vials) | ||
| 9 | 00894030002413 | ALL02AB0210 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace Pro Control Solution (L1/Normal; L2/High) | ||
| 10 | 00894030002703 | APX02AB0510 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Control Solution Low | ||
| 11 | 00894030002475 | APX01GS0100-S | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | EmbraceEVO Gestational Diabetes Package - SMALL (5 vials) | ||
| 12 | 00894030002420 | APX01AB0851 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace EVO Mini Meter, all-in-one kit, RETAIL | ||
| 13 | 00894030002345 | APX02AB0810 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace EVO Control Solution, L1 (Low) | ||
| 14 | 00894030002079 | APX02AB310 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace Control Solution, L1 (Low) | ||
| 15 | 00894030002024 | APX02AB0202 | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace Strips, 50ct Vial - Distributor partner | ||
| 16 | 00894030002086 | APX02AB0200 | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace Strips, 10-ct | ||
| 17 | 00894030002062 | APX02AB0311 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace Control Solution, L2 (High) | ||
| 18 | 00894030002352 | APX02AB0802 | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace EVO Strips, 50ct Vial - RETAIL | ||
| 19 | 00894030002338 | APX02AB0202MO | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace Strips, 50ct Vial - Mail Order (Yellow Band) | ||
| 20 | 00894030002680 | APX02AB0502 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace 50ct Test Strip | ||
| 21 | 00894030002406 | ALL02AB0202 | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace Pro Strips, 50-ct vials | ||
| 22 | 00894030002390 | ALL01AB0200 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Pro Meter | ||
| 23 | 00894030002260 | APX01AB0300 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Meter Kit (w/10 ct) | ||
| 24 | 00894030002567 | APX01GS0200-L | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Gestational Diabetes Package - LARGE (9 vials) | ||
| 25 | 00894030002550 | APX01GS0200-S | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Gestational Diabetes Package - SMALL (5 vials) |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00851225008032 | 2100-050 | Lucidplus Glucose Test strips 50 count | VIDAN DIAGNOSTICS LLC | ||
| 2 | 00851225008001 | 300300 | LucidPlus B-Ketone Plus Blood Glucose Monitoring System | VIDAN DIAGNOSTICS LLC | ||
| 3 | 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. | |
| 4 | 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. | |
| 5 | 00850632007362 | 1 | Blood Glucose Monitor for use with Easy Trak II Testing Strips only | Easy Trak II Blood Glucose Meter | HOME AIDE DIAGNOSTICS, INC. | |
| 6 | 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. | |
| 7 | 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. | |
| 8 | 00850578007044 | GLUCOSE TEST STRIP 50 CT. | HEPRO.US GLUCOSE TEST STRIPS 50units/BX for MM1000 | GLUCOSE TEST STRIP 50 CT. | HEPRO.US INC. | |
| 9 | 00850229007195 | 405 | E002-405 | Analyzer Quality Control | DriDye 405 | AWARENESS TECHNOLOGY, INCORPORATED |
| 10 | 00850229007188 | 405/ 450 | Analyzer Quality Control | DriDye 405/ 450 | AWARENESS TECHNOLOGY, INCORPORATED | |
| 11 | 00850229007171 | 450 | E002-450 | Analyzer Quality Control | DriDye 450 | AWARENESS TECHNOLOGY, INCORPORATED |
| 12 | 00850229007164 | 492 | E002-492 | Analyzer Quality Control | DriDye 492 | AWARENESS TECHNOLOGY, INCORPORATED |
| 13 | 00850212007089 | 2130166 | Vitamin D Control | FUJIREBIO DIAGNOSTICS, INC. | ||
| 14 | 00850212007034 | 2130152 | Vitamin D Control | FUJIREBIO DIAGNOSTICS, INC. | ||
| 15 | 00850081003960 | BLE-TS50-FDA | Glucose Test Strips | BLE Smart® Test Strips | ENTRA HEALTH SYSTEMS LLC | |
| 16 | 00850081003212 | MGH-CS3 | Control Solution 3 Pak | MyGlucoHealth® Control Solution 3-Pack | ENTRA HEALTH SYSTEMS LLC | |
| 17 | 00850081003007 | MGH-BT1 | Blood Glucose Meter Kit | MyGlucoHealth® BT Meter Kit | ENTRA HEALTH SYSTEMS LLC | |
| 18 | 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 | |
| 19 | 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 | |
| 20 | 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 | |
| 21 | 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 | |
| 22 | 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 | |
| 23 | 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 | |
| 24 | 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 | |
| 25 | 00850065006215 | 1054-05 | Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitor Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System manufactured by Labstyle Innovation Ltd. to check that the meter and test strips are working together properly for self-testing. | Dario Glucose Control Solution | LABSTYLE INNOVATION LTD | |
| 26 | 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 | |
| 27 | 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 | |
| 28 | 00850065006048 | 1054-01 | Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitor Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System manufactured by Labstyle Innovation Ltd. to check that the meter and test strips are working together properly for self-testing. | Dario Glucose Control Solution | LABSTYLE INNOVATION LTD | |
| 29 | 00850042929049 | HH-XIII-T | TeleBGM Lancing Device | Mio Lancing Device | MIO | MIO LABS INC. |
| 30 | 00850042929032 | I | Mio Single Use Lancets | MIO | MIO LABS INC. | |
| 31 | 00850042929025 | VGC01 | TeleBGM Control Solution | Mio Control Solution | MIO | MIO LABS INC. |
| 32 | 00850042929018 | VGS01 | TeleBGM Test Strip | Blood Glucose Test Strip | MIO | MIO LABS INC. |
| 33 | 00850042929001 | VGM04 | TeleBGM Gen-1(BLE) | Blood Glucose Meter | MIO | MIO LABS INC. |
| 34 | 00850028714751 | FP810-WM | FifthPulse | JEG & SONS INC. | ||
| 35 | 00850028714614 | FP607-GK | FifthPulse | JEG & SONS INC. | ||
| 36 | 00850028714508 | FP100-L | FifthPulse | JEG & SONS INC. | ||
| 37 | 00850028714492 | FP100-TS | FifthPulse | JEG & SONS INC. | ||
| 38 | 00850026094312 | FP050-L | FifthPulse | JEG & SONS INC. | ||
| 39 | 00850026094305 | FP050-TS | FifthPulse | JEG & SONS INC. | ||
| 40 | 00850026094299 | FP607-G | FifthPulse | JEG & SONS INC. | ||
| 41 | 00850017460065 | S5640988 | S5640988 | 25s | BIOCOACH Blood Glucose Test Strips 25s | AMVENTUREX, INC. |
| 42 | 00850017460058 | S5800382 | S5800382 | Level 1 & 2 | BIOCOACH Glucose Control Solution L1/L2 | AMVENTUREX, INC. |
| 43 | 00850017460034 | S84102 | S84102 | Complete Kit | BIOCOACH Blood Glucose and Ketone Monitoring System | AMVENTUREX, INC. |
| 44 | 00850017460027 | S5640989 | S5640989 | 50s | BIOCOACH Blood Glucose Test Strips 50s | AMVENTUREX, INC. |
| 45 | 00850014981051 | TD-4277 | Medibio TD-4277 Blood Glucose Test Strips 50pcs | MEDIBIO USA LLC | ||
| 46 | 00850014981013 | TD-4277 | Medibio TD-4277 Blood Glucose Monitoring System | MEDIBIO USA LLC | ||
| 47 | 00850014861049 | TD-4289 | HeartsCare C1 multi-functional monitoring system | HEARTS BIO, INC. | ||
| 48 | 00850011135495 | 801mm | aHBs Calibration Verification / Linearity Test kit | Validate | LGC CLINICAL DIAGNOSTICS, INC. | |
| 49 | 00850011135457 | 506ro | Validate VIT D Single clinical chemistry analyte IVD, control | VALIDATE | LGC CLINICAL DIAGNOSTICS, INC. | |
| 50 | 00850011135402 | 510mm | Validate SARS-Cov2 IgG Single clinical chemistry analyte IVD, control | Validate | LGC CLINICAL DIAGNOSTICS, INC. |