| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00885325000849 | 164446-201 | CareSens N Voice Multi Blood Glucose Monitoring System | NBW | System, Test, Blood Glucose, Over The Counter | 2 | CareSens N Voice Multi | |
| 2 | 00885325000764 | 520050 | COOL Blood Glucose Test Strip | CGA | Glucose Oxidase, Glucose | COOL | ||
| 3 | 00885325001426 | 343105 | Tempo Blood Glucose Test Strip | CGA | Glucose Oxidase, Glucose | Tempo | ||
| 4 | 00885325000443 | 164442-202 | CareSens N Voice Blood Glucose Meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | CareSens N Voice | |
| 5 | 00885325000047 | 155300-201 | CareSens N Blood Glucose Meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | CareSens N (MedPoint Diagnostics) | |
| 6 | 00857513006209 | 282104-201 | VeraSens Voice Blood Glucose Test Strip | CGA | Glucose Oxidase, Glucose | VeraSens Voice | ||
| 7 | 00857513006193 | 282442 | VeraSens Voice Blood Glucose Meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | VeraSens Voice | |
| 8 | 00892896000260 | 163424-201 | Fifty50 Sport Blood Glucose Monitoring System 2.0 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Fifty50 Sport | ||
| 9 | 00885325000863 | 276151 | KetoSens B-Ketone Test Strip (individual foiled packs x 50) | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | KetoSens | ||
| 10 | 00885325000856 | 276261-201 | KetoSens B-Ketone Monitoring System with Lancets | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | KetoSens | |
| 11 | 00885325001075 | 276262 | KetoSens B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | KetoSens | |
| 12 | 00885325001068 | 276154 | KetoSens B-Ketone Test Strips (individually foiled packs x 50) with 50T lancets | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | KetoSens | ||
| 13 | 00885325000870 | 276153-206 | KetoSens B-Ketone Test Strip (individual foiled packs x 10) | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | KetoSens | ||
| 14 | 00885325001198 | 276150 | KetoSens B-Ketone Test Strip (individual foiled packs x 30) | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | KetoSens | ||
| 15 | 00885325001693 | 164503 | CareSens N Feliz Blood Glucose Monitoring System | NBW | System, Test, Blood Glucose, Over The Counter | 2 | CareSens N Feliz | |
| 16 | 00885325001495 | 276265 | KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | KetoSens | |
| 17 | 00885325001280 | 276156 | KetoSens B-Ketone 10T Test Strips with 10T lancets | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | KetoSens | ||
| 18 | 00885325001273 | 276155 | KetoSens B-Ketone Test Strip (individually foiled packs x 30) with 30T lancets | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | KetoSens | ||
| 19 | 00885325001266 | 164221 | CareSens II Blood Glucose Monitoring System (Basic meter set) | NBW | System, Test, Blood Glucose, Over The Counter | 2 | CareSens II | |
| 20 | 00885325000757 | 520001 | COOL Blood Glucose Meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | COOL | |
| 21 | 00885325000375 | 521100 | COOL Blood Glucose Monitoring System | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | COOL | |
| 22 | 00885325001686 | 164508 | CareSens N Feliz BT Blood Glucose Monitoring System | NBW | System, Test, Blood Glucose, Over The Counter | 2 | CareSens N Feliz BT | |
| 23 | 00885325001419 | 343104 | Tempo Blood Glucose Test Strip | CGA | Glucose Oxidase, Glucose | Tempo | ||
| 24 | 00885325001402 | 343262 | Tempo Blood Glucose Monitoring System | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Tempo | |
| 25 | 00885325001389 | 343264 | Tempo Blood Glucose Monitoring System | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Tempo | |
| 26 | 00885325000610 | 164104-204 | CareSens N Multi Blood Glucose Test Strip | CGA | Glucose Oxidase, Glucose | CareSens N Multi | ||
| 27 | 00885325001372 | 164372 | CareSens N Plus BT Blood Glucose Monitoring System | NBW | System, Test, Blood Glucose, Over The Counter | 2 | CareSens N Plus BT | |
| 28 | 00885325000818 | 520010 | COOL Blood Glucose Test Strip | CGA | Glucose Oxidase, Glucose | COOL | ||
| 29 | 00885325000436 | 164422 | CareSens N POP Blood Glucose Monitoring System | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | CareSens N POP | |
| 30 | 00885325000115 | 164301-202 | CareSens N Blood Glucose Meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | CareSens N | |
| 31 | 00885325001105 | 164303-203 | CareSens N Blood Glucose Monitoring System (White) | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | CareSens N | |
| 32 | 00885325001327 | 164307 | CareSens N Blood Glucose Monitoring System | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | CareSens N | |
| 33 | 00885325001310 | 164284 | CareSens N Blood Glucose Monitoring System | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | CareSens N | |
| 34 | 00885325001242 | 164101 | CareSens N Blood Glucose Test Strip | CGA | Glucose Oxidase, Glucose | CareSens N | ||
| 35 | 00885325000023 | 164104-203 | CareSens N Blood Glucose Test Strip | CGA | Glucose Oxidase, Glucose | CareSens N | ||
| 36 | 00885325000016 | 164303-201 | CareSens N Blood Glucose Monitoring System | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | CareSens N | |
| 37 | 00885325001211 | 164303-204 | CareSens N Blood Glucose Monitoring System with Test Strips (10T) | NBW | System, Test, Blood Glucose, Over The Counter | 2 | CareSens N | |
| 38 | 00892896000093 | 163604 | Fifty50 Blood Glucose Test Strip | CGA | Glucose Oxidase, Glucose | Fifty50 | ||
| 39 | 00892896000086 | 163308-302 | Fifty50 Blood Glucose Monitoring System 2.0 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Fifty50 | |
| 40 | 00892896000017 | 163140 | Fifty50 Blood Glucose Test Strip | CGA | Glucose Oxidase, Glucose | Fifty50 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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 |
| 2 | 10612479212784 | 5059 | GLUCOSE TEST STRIP WITH PURPLE COLOR | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 3 | 10385480434376 | GLU | 43437 | Nova Max Glucose Test Strips | NOVA MAX | NOVA BIOMEDICAL CORPORATION |
| 4 | 10385480422144 | GLU Test Strip | 42214 | StatStrip StatStrip Xpress Glu - Test Strips | StatStrip | NOVA BIOMEDICAL CORPORATION |
| 5 | 10304040037734 | 5700412 | 5700412 | CardioChek 15Lipid/15Glucose | CardioChek | HENRY SCHEIN, INC. |
| 6 | 10304040037727 | 5700415 | 5700415 | Cardiochek eGLU Glucose Test | CardioChek | HENRY SCHEIN, INC. |
| 7 | 10052569138479 | TRUEtrack PRE-PACK | A4089-75 | Health Mart PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 8 | 10021292008625 | TRUEtrack PRE-PACK | A4027-75 | Preferred Plus Pharmacy TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 9 | 10021292008618 | TRUEtrack PRE-PACK | A4011-75 | GOOD NEIGHBOR PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 10 | 10021292006874 | TRUEtrack PRE-PACK | A4088-75 | HealthWise PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 11 | 10021292006867 | TRUEtrack PRE-PACK | A4054-75 | Sunmark TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 12 | 10021292006843 | TRUEtrack PRE-PACK | A4H01-75 | TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 13 | 08809301168134 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 14 | 08809301168127 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 15 | 08809301168110 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 16 | 08809301168103 | GT-301 | GlucoTrack VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 17 | 08809301168097 | GT-301 | GlucoTrack VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 18 | 08809301168080 | GT-301 | GlucoTrack Voice Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 19 | 08809301168042 | GT-S01 | GlucoTrack Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 20 | 08809301168011 | GT-S01 | GlucoTrack Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 21 | 08809301166031 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 22 | 08809301166017 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 23 | 08809301166000 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 24 | 08809301161760 | PS-004 | Pip Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 25 | 08809301161036 | PS-004 | Gmate® Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 26 | 08809301161029 | PS-004 | Gmate® Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 27 | 08809301160862 | PG-310 | Pip Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 28 | 08809301160411 | PG-101 | Gmate Smart Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 29 | 08809301160213 | PG-301 | Gmate® VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 30 | 08809301160206 | PG-310 | Gmate® Origin Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 31 | 08809301160169 | PG-201 | Gmate® STEP Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 32 | 08809301160152 | PG-200 | Gmate® mini Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 33 | 08809301160145 | PG-310 | Gmate® Origin Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 34 | 08809301160138 | PG-301 | Gmate® VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 35 | 08809301160121 | PG-201 | Gmate® STEP Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 36 | 08809301160114 | PG-200 | Gmate® mini Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 37 | 08809301160084 | PG-301 | Gmate® VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 38 | 08809301160077 | PG-310 | Gmate® Origin Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 39 | 08809301160022 | PG-201 | Gmate® STEP Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 40 | 08809301160015 | PG-200 | Gmate® mini Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 41 | 08809115908971 | IGM-0021B | Blood Glucose Monitoring System | Element™Plus Meter | OSANG HEALTHCARE CO., LTD. | |
| 42 | 08809115908957 | IGM-0021B | Blood Glucose Monitoring System | Element™Plus Test Strips | OSANG HEALTHCARE CO., LTD. | |
| 43 | 08809115908452 | IGM-0021B | Blood Glucose Monitoring System | Element™ Meter | OSANG HEALTHCARE CO., LTD. | |
| 44 | 08809115908438 | IGM-0021B | Blood Glucose Monitoring System | Element™ Test Strips | OSANG HEALTHCARE CO., LTD. | |
| 45 | 07311091207074 | 120707 | 120707 | HemoCue Glucose 201 Analyzer mmol/L whole blood | HemoCue® Glucose 201 Analyzer | HEMOCUE AB |
| 46 | 07311091207067 | 120706 | 120706 | HemoCue Glucose 201 Analyzer mg/dL plasma | HemoCue® Glucose 201 Analyzer | HEMOCUE AB |
| 47 | 06971292001423 | DS-W10050011 | The DS-W Blood Glucose Monitoring System is intended for use outside the body (i The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing purposes and only with fresh whole blood samples. It should not be used for the diagnosis of diabetes. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
| 48 | 06971292001416 | DS-W10050011 | The DS-W Blood Glucose Monitoring System is intended for use outside the body (i The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing purposes and only with fresh whole blood samples. It should not be used for the diagnosis of diabetes. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
| 49 | 06971292001409 | DS-W15050011 | The DS-W Blood Glucose Monitoring System is intended for use outside the body (i The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing purposes and only with fresh whole blood samples. It should not be used for the diagnosis of diabetes. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
| 50 | 06971292001393 | DS-W1001002 | The DS-W Blood Glucose Monitoring System is intended for use outside the body (i The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing purposes and only with fresh whole blood samples. It should not be used for the diagnosis of diabetes. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. |