| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 17311091118124 | 111812 | 111812 | HemoCue Hb 301 Microcuvettes 4x50 vial | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 301 Microcuvettes |
| 2 | 17311091118094 | 111809 | 111809 | HemoCue Hb 301 Microcuvettes 4x50 vial | GKR | System, Hemoglobin, Automated | HemoCue® Hb 301 Microcuvettes | |
| 3 | 17311091118070 | 111807 | 111807 | HemoCue Hb 301 Microcuvettes 4x75 vial | GKR | System, Hemoglobin, Automated | HemoCue® Hb 301 Microcuvettes | |
| 4 | 17311091118018 | 111801 | 111801 | HemoCue Hb 301 Microcuvettes 4x50 vial | GKR | System, Hemoglobin, Automated | HemoCue® Hb 301 Microcuvettes | |
| 5 | 07311091214447 | 121444 | 121444 | HemoCue Glucose 201 DM Analyzer mmol/L plasma | LFR | Glucose Dehydrogenase, Glucose | 2 | HemoCue® Glucose 201 DM Analyzer |
| 6 | 07311091214225 | 121422 | 121422 | HemoCue Glucose 201 DM Analyzer mg/dL plasma | LFR | Glucose Dehydrogenase, Glucose | 2 | HemoCue® Glucose 201 DM Analyzer |
| 7 | 07311091219206 | 121920 | 121920 | HemoCue Hb 801 Analyzer g/dL | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 801 Analyzer |
| 8 | 07311091211460 | 121146 | 121146 | HemoCue Hb 201 DM Analyzer g/L | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 201 DM Analyzer |
| 9 | 07311091211354 | 121135 | 121135 | HemoCue Hb 201 DM Analyzer g/dL | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 201 DM Analyzer |
| 10 | 17311091218046 | 121804 | 121804 | HemoCue Hb301 Analyzer g/dL | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb301 Analyzer |
| 11 | 17311091107234 | 110723 | 110723 | HemoCue Glucose 201 Microcuvettes 2x25 single | CGA | Glucose Oxidase, Glucose | 2 | HemoCue® Glucose 201 Microcuvettes |
| 12 | 17311091107067 | 110706 | 110706 | HemoCue Glucose 201 Microcuvettes 4x25 vial | CGA | Glucose Oxidase, Glucose | HemoCue® Glucose 201 Microcuvettes | |
| 13 | 17311091107050 | 110705 | 110705 | HemoCue Glucose 201 Microcuvettes 4x25 single | CGA | Glucose Oxidase, Glucose | 2 | HemoCue® Glucose 201 Microcuvettes |
| 14 | 07311091218278 | 121827 | 121827 | HemoCue Hb301 Analyzer g/dL | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb301 Analyzer |
| 15 | 07311091203144 | 120314 | 120314 | HemoCue Plasma/Low Hb Photometer mg/dL | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Plasma/Low Hb Photometer |
| 16 | 17311091117325 | 111732 | 111732 | HemoCue Hb 201 Microcuvettes 4x25 single | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 201 Microcuvettes |
| 17 | 17311091117318 | 111731 | 111731 | HemoCue Hb 201 Microcuvettes 4x50 vial | GKR | System, Hemoglobin, Automated | HemoCue® Hb 201 Microcuvettes | |
| 18 | 17311091117165 | 111716 | 111716 | HemoCue Hb 201 Microcuvettes 4x50 vial | GKR | System, Hemoglobin, Automated | HemoCue® Hb 201 Microcuvettes | |
| 19 | 17311091117158 | 111715 | 111715 | HemoCue Hb 201 Microcuvettes 4x25 single | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 201 Microcuvettes |
| 20 | 07311091230010 | 123001 | 123001 | HemoCue WBC Analyzer x10^9 /L | GKL | Counter, Cell, Automated (Particle Counter) | 2 | HemoCue® WBC Analyzer |
| 21 | 17311091130034 | 113003 | 113003 | HemoCue WBC Microcuvettes 4x40 vial | GKL | Counter, Cell, Automated (Particle Counter) | HemoCue® WBC Microcuvettes | |
| 22 | 17311091103021 | 110302 | 110302 | HemoCue Plasma/Low Hb Microcuvettes 4x25 vial | GKR | System, Hemoglobin, Automated | HemoCue® Plasma/Low Hb Microcuvettes | |
| 23 | 07311091217219 | 121721 | 121721 | HemoCue Hb 201+ Analyzer g/dL | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 201+ Analyzer |
| 24 | 07311091217202 | 121720 | 121720 | HemoCue Hb 201+ Analyzer g/L | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 201+ Analyzer |
| 25 | 07311091207067 | 120706 | 120706 | HemoCue Glucose 201 Analyzer mg/dL plasma | CGA | Glucose Oxidase, Glucose | 2 | HemoCue® Glucose 201 Analyzer |
| 26 | 17311091119022 | 111902 | 111902 | HemoCue Hb 801 Microcuvettes 4x50 vial | GKR | System, Hemoglobin, Automated | HemoCue® Hb 801 Microcuvettes | |
| 27 | 17311091106084 | 110608 | 110608 | HemoCue Urine Albumin Microcuvettes 2x25 single | KQO | Automated Urinalysis System | HemoCue® Urine Albumin Microcuvettes | |
| 28 | 07311091391681 | 139168 | 139168 | HemoCue® 801 Connect | JQP | Calculator/Data Processing Module, For Clinical Use | 1 | HemoCue® 801 Connect |
| 29 | 07311091206237 | 120623 | 120623 | HemoCue Albumin 201 Analyzer mg/L | KQO | Automated Urinalysis System | 1 | HemoCue® Albumin 201 Analyzer |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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) | GE | BIONIME CORPORATION |
| 2 | 10850081003011 | MGH-TS50-FDA | Glucose Test Strip Vial Label | MyGlucoHealth Test Strips | ENTRA HEALTH SYSTEMS LLC | |
| 3 | 10763924550507 | MD550 | Lipid and Glucose Measuring System | LipidPlus® Meter | JANT PHARMACAL CORPORATION | |
| 4 | 10758750031795 | 6844295 | 6844295 | VITROS XT Chemistry Products GLU-Ca Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 5 | 10758750009572 | 1707801 | 1707801 | VITROS Chemistry Products GLU Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 6 | 10673486000719 | Glucopad Blood Glucose Monitoring System | G852-C-001 | Glucopad Blood Glucose Monitoring System (BGMS) is for self testing use and it c Glucopad Blood Glucose Monitoring System (BGMS) is for self testing use and it consists of a blood glucose meter, and blood glucose test strips. | TECO DIAGNOSTICS | TECO DIAGNOSTICS |
| 7 | 10612479212784 | 5059 | GLUCOSE TEST STRIP WITH PURPLE COLOR | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 8 | 10385480434376 | GLU | 43437 | Nova Max Glucose Test Strips | NOVA MAX | NOVA BIOMEDICAL CORPORATION |
| 9 | 10385480422144 | GLU Test Strip | 42214 | StatStrip StatStrip Xpress Glu - Test Strips | StatStrip | NOVA BIOMEDICAL CORPORATION |
| 10 | 10304040037734 | 5700412 | 5700412 | CardioChek 15Lipid/15Glucose | CardioChek | HENRY SCHEIN, INC. |
| 11 | 10304040037727 | 5700415 | 5700415 | Cardiochek eGLU Glucose Test | CardioChek | HENRY SCHEIN, INC. |
| 12 | 10052569138479 | TRUEtrack PRE-PACK | A4089-75 | Health Mart PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 13 | 10021292008625 | TRUEtrack PRE-PACK | A4027-75 | Preferred Plus Pharmacy TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 14 | 10021292008618 | TRUEtrack PRE-PACK | A4011-75 | GOOD NEIGHBOR PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 15 | 10021292006874 | TRUEtrack PRE-PACK | A4088-75 | HealthWise PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 16 | 10021292006867 | TRUEtrack PRE-PACK | A4054-75 | Sunmark TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 17 | 10021292006843 | TRUEtrack PRE-PACK | A4H01-75 | TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 18 | 08809301168134 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 19 | 08809301168127 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 20 | 08809301168110 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 21 | 08809301168103 | GT-301 | GlucoTrack VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 22 | 08809301168097 | GT-301 | GlucoTrack VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 23 | 08809301168080 | GT-301 | GlucoTrack Voice Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 24 | 08809301168042 | GT-S01 | GlucoTrack Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 25 | 08809301168011 | GT-S01 | GlucoTrack Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 26 | 08809301166031 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 27 | 08809301166017 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 28 | 08809301166000 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 29 | 08809301161760 | PS-004 | Pip Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 30 | 08809301161036 | PS-004 | Gmate® Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 31 | 08809301161029 | PS-004 | Gmate® Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 32 | 08809301160862 | PG-310 | Pip Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 33 | 08809301160411 | PG-101 | Gmate Smart Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 34 | 08809301160213 | PG-301 | Gmate® VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 35 | 08809301160206 | PG-310 | Gmate® Origin Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 36 | 08809301160169 | PG-201 | Gmate® STEP Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 37 | 08809301160152 | PG-200 | Gmate® mini Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 38 | 08809301160145 | PG-310 | Gmate® Origin Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 39 | 08809301160138 | PG-301 | Gmate® VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 40 | 08809301160121 | PG-201 | Gmate® STEP Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 41 | 08809301160114 | PG-200 | Gmate® mini Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 42 | 08809301160084 | PG-301 | Gmate® VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 43 | 08809301160077 | PG-310 | Gmate® Origin Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 44 | 08809301160022 | PG-201 | Gmate® STEP Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 45 | 08809301160015 | PG-200 | Gmate® mini Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 46 | 08809115908971 | IGM-0021B | Blood Glucose Monitoring System | Element™Plus Meter | OSANG HEALTHCARE CO., LTD. | |
| 47 | 08809115908957 | IGM-0021B | Blood Glucose Monitoring System | Element™Plus Test Strips | OSANG HEALTHCARE CO., LTD. | |
| 48 | 08809115908452 | IGM-0021B | Blood Glucose Monitoring System | Element™ Meter | OSANG HEALTHCARE CO., LTD. | |
| 49 | 08809115908438 | IGM-0021B | Blood Glucose Monitoring System | Element™ Test Strips | OSANG HEALTHCARE CO., LTD. | |
| 50 | 07311091207074 | 120707 | 120707 | HemoCue Glucose 201 Analyzer mmol/L whole blood | HemoCue® Glucose 201 Analyzer | HEMOCUE AB |