No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00015482740504 | 740050 | Blood Glucose Test Strips | CGA | GLUCOSE OXIDASE, GLUCOSE | GLUCOCARD® 01 BLOOD GLUCOSE TEST STRIPS | ||
2 | 00015482183103 | 18310 | Dry Chemistry Analyzer IVD, semi-automated | CGA | GLUCOSE OXIDASE, GLUCOSE | 2 | SPOTCHEM™ EZ Analyzer | |
3 | 00015482771195 | 77119 | Strip Description: For the in vitro quantitative determination of magnesium con Strip Description: For the in vitro quantitative determination of magnesium concentration in human plasma from whole blood samples. | JGJ | PHOTOMETRIC METHOD, MAGNESIUM | SPOTCHEM™ II Magnesium | ||
4 | 00015482771089 | 77108 | Strip Description: For the in vitro quantitative determination of total protein Strip Description: For the in vitro quantitative determination of total protein in human plasma from whole blood samples. | CIX | BROMCRESOL GREEN DYE-BINDING, ALBUMIN | SPOTCHEM™ II Total Protein | ||
5 | 00015482771065 | 77106 | Strip Description: For the in vitro quantitative determination of total bilirub Strip Description: For the in vitro quantitative determination of total bilirubin concentration in human plasma from whole blood samples. | CIX | BROMCRESOL GREEN DYE-BINDING, ALBUMIN | SPOTCHEM™ II Total Bilirubin | ||
6 | 00015482771034 | 77103 | Strip Description: For the in vitro quantitative determination of total cholest Strip Description: For the in vitro quantitative determination of total cholesterol in human plasma from whole blood samples. | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | SPOTCHEM™ II Total Cholesterol | ||
7 | 00015482720506 | 720050 | Blood Glucose Test Strips | CGA | GLUCOSE OXIDASE, GLUCOSE | GLUCOCARD® 01 BLOOD GLUCOSE TEST STRIPS | ||
8 | 00015482540050 | 540005 | GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose t GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540050 is used as the assigned UDI for the Class I device.) | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GLUCOCARD® Shine Level 1 Control Solution | |
9 | 00015482502959 | 250295 | Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. | MEG | Syringe, Antistick | 2 | ASSURE® ID Safety Syringe .5mL 29G x 1/2" | |
10 | 00015482275310 | 275131 | Insulin Safety Pen Needle. Intended to be used with a pen injector device for t Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, Hypodermic, Single Lumen | Assure® ID Safety Pen Needle 5mm x 31g 100's | ||
11 | 00015482129743 | 102974 | Urine Analyzer utilize reflectance technology with with AUTION Strips reagent t Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity. | JMT,JIN,JRE,JIR,JJB,JIO,KQO,CEN,CDM,JIL,LJX | DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT),NITROPRUSSIDE, KETONES (URINA DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT),NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.),REFRACTOMETER FOR CLINICAL USE,INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.),AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.),BLOOD, OCCULT, COLORIMETRIC, IN URINE,AUTOMATED URINALYSIS SYSTEM,DYE-INDICATOR, PH (URINARY, NON-QUANT.),DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.),METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE),TEST, URINE LEUKOCYTE | 1 | AUTION™ MAX AX-4022 Analyzer | |
12 | 30015482571994 | 571199 | Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU | CGA,NBW | GLUCOSE OXIDASE, GLUCOSE,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | GLUCOCARD® Expression™ Blood Glucose Monitoring System | |
13 | 30015482571888 | 571188 | DME: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU | NBW,CGA | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,GLUCOSE OXIDASE, GLUCOSE | 2 | GLUCOCARD® Expression™ Blood Glucose Monitoring System | |
14 | 04987486738060 | 73806 | Aution AU Control Solution is supplied in 2 different levels (High and Low) and Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.) | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | Aution™ AU Control Solution | |
15 | 04987486015147 | 103400 | The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used fo The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used for the quantitative determination of Hemoglobin A1c (HbA1c) in human whole blood and hemolysate samples. Bi-level calibrators (low and high) lyophilized calibrator from human-sourced hemoglobin. | JIT | Calibrator, Secondary | 2 | Calibrator 80 | |
16 | 04987486001973 | 100675 | The ADAMS A1c HA-8180V system is intended for the quantitative determination of The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC). | PDJ | Hemoglobin A1c Test System | 2 | ADAMS™ A1c HA-8180V (UL) Analyzer | |
17 | 00015482230296 | 230129 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, hypodermic, single lumen | TechLITE PEN NEEDLES | ||
18 | 00015482571108 | 571100 | Portable Blood Glucose Meter | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | GLUCOCARD® EXPRESSION Blood Glucose Monitoring System | ||
19 | 00015482771225 | 77122 | Strip Description: For the in vitro quantitative determination of HDL-Cholester Strip Description: For the in vitro quantitative determination of HDL-Cholesterol in human plasma from whole blood samples. | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | SPOTCHEM™ II HDL-Cholesterol | ||
20 | 00015482771201 | 77120 | Strip Description: For the in vitro quantitative determination of lactate dehyd Strip Description: For the in vitro quantitative determination of lactate dehydrogenase (LDH) activity in human plasma from whole blood samples. | CFH | TETRAZOLIUM INT DYE-DIAPHORASE, LACTATE DEHYDROGENASE | SPOTCHEM™ II LDH | ||
21 | 00015482771119 | 77111 | Strip Description: For the in vitro quantitative determination of ALT (alanine Strip Description: For the in vitro quantitative determination of ALT (alanine aminotransferease or glutamic pyruvic transaminase) activity in human plasma from whole blood samples. | CGA | GLUCOSE OXIDASE, GLUCOSE | SPOTCHEM™ II ALT / GPT | ||
22 | 00015482761103 | 761100 | Portable Blood Glucose Meter with Test Strips | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | GLUCOCARD® Vital™ BLOOD GLUCOSE METER | |
23 | 00015482760205 | 760020 | Portable Blood Glucose Meter | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | GLUCOCARD® Vital™ BLOOD GLUCOSE METER | |
24 | 00015482760014 | 760001 | Portable Blood Glucose Meter | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | GLUCOCARD® Vital™ BLOOD GLUCOSE METER | |
25 | 00015482570101 | 570001 | Portable Blood Glucose Meter | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | GLUCOCARD® EXPRESSION Blood Glucose Monitoring System | ||
26 | 00015482544102 | 544110 | The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. | NBW | System, Test, Blood Glucose, Over The Counter | 2 | GLUCOCARD® Shine Express Blood Glucose Monitoring System | |
27 | 00015482542108 | 542110 | The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quant The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. | NBW | System, Test, Blood Glucose, Over The Counter | 2 | GLUCOCARD® Shine XL Blood Glucose Monitoring System | |
28 | 00015482541002 | 541100 | The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantita The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes. | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | GLUCOCARD® Shine Blood Glucose Monitoring System | ||
29 | 00015482530501 | 530050 / 530100 | Blood Glucose Test Strips | CGA | GLUCOSE OXIDASE, GLUCOSE | ASSURE® PRISM MULTI BLOOD GLUCOSE TEST STRIPS | ||
30 | 00015482502300 | 502030 | N/A | Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the qua Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (in vitro diognostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as a aid to monitor the effectiveness of diabetes control. | CGA | Glucose Oxidase, Glucose | Assure® Platinum | |
31 | 00015482232290 | 232129 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, hypodermic, single lumen | TechLITE PEN NEEDLES | ||
32 | 00015482232993 | 232929 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, hypodermic, single lumen | TechLITE PEN NEEDLES | ||
33 | 00015482230999 | 230929 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, hypodermic, single lumen | TechLITE PEN NEEDLES | ||
34 | 00015482238919 | 238931 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, hypodermic, single lumen | TechLITE PEN NEEDLES | ||
35 | 00015482238322 | 238132 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, hypodermic, single lumen | TechLITE PEN NEEDLES | ||
36 | 00015482238315 | 238131 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, hypodermic, single lumen | TechLITE PEN NEEDLES | ||
37 | 00015482236328 | 236132 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, hypodermic, single lumen | TechLITE PEN NEEDLES | ||
38 | 00015482236311 | 236131 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, hypodermic, single lumen | TechLITE PEN NEEDLES | ||
39 | 00015482235918 | 235931 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, hypodermic, single lumen | TechLITE PEN NEEDLES | ||
40 | 00015482235314 | 235131 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of drugs. | FMI | Needle, Hypodermic, Single Lumen | TechLITE PEN NEEDLES | ||
41 | 00015482234928 | 234932 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, hypodermic, single lumen | TechLITE PEN NEEDLES | ||
42 | 00015482234324 | 234132 | Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. | FMI | Needle, hypodermic, single lumen | TechLITE PEN NEEDLES | ||
43 | 00015482145057 | 14505 | Urine Analyzer utilize reflectance technology with with AUTION Strips reagent t Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity. | KQO | AUTOMATED URINALYSIS SYSTEM | 1 | AUTION™ MAX AX-4030 Analyzer | |
44 | 30015482542994 | 542199 | Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, te Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, test strips, IFU | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GLUCOCARD® Shine XL Blood Glucose Monitoring System | |
45 | 30015482541997 | 541199 | Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU | CGA,NBW | GLUCOSE OXIDASE, GLUCOSE,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | GLUCOCARD® Shine Blood Glucose Monitoring System | |
46 | 04987486738107 | 73810 | Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. | KQO | AUTOMATED URINALYSIS SYSTEM | 1 | AUTION™ Staining Solution BAC | |
47 | 04987486009801 | 102478 | Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL o Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL of each level per box). They are supplied in liquid form, requiring no pretreatment or dilution. They are prepared by adding various compounds to human urine so that the desired reaction occurs during quality control. Preservatives have been added to prevent bacteria growth. (Primary UPC/EAN-13# 4987486009801 is used as the assigned UDI for the Class I device.) | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | AUTION Check Plus Controls | |
48 | 00015482771171 | 77117 | Strip Description: For the in vitro quantitative determination of fructosamine Strip Description: For the in vitro quantitative determination of fructosamine in human plasma from whole blood samples. | CGA | GLUCOSE OXIDASE, GLUCOSE | SPOTCHEM™ II Fructosamine | ||
49 | 00015482771140 | 77114 | Strip Description: For the in vitro quantitative determination of GGT (y-glutam Strip Description: For the in vitro quantitative determination of GGT (y-glutamyltransferase or y-glutamyl tanspeptidase, Y-GPT) activity in human plasma from whole blood samples. | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | SPOTCHEM™ II GGT | ||
50 | 30015482761999 | 761199 | Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU | CGA,NBW | GLUCOSE OXIDASE, GLUCOSE,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | GLUCOCARD® Vital™ Blood Glucose Monitoring System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00857513006193 | 282442 | VeraSens Voice Blood Glucose Meter | VeraSens Voice | I-SENS, INC. | |
2 | 00856276008826 | 30190 | 30190 | Glucertain Glucose Cntrol Solution, High, 50/box, 12 boxes/case | Glucertain | CELLERA LLC |
3 | 00856276008819 | 30180 | 30180 | Glucertain Glucose Control Solution, Low, 50/box, 12 boxes/case | Glucertain | CELLERA LLC |
4 | 00856176008056 | 00856176008056 | 00856176008056 | Blood glucose test cartridges with 10 tests per cartridge. Five cartridges per t Blood glucose test cartridges with 10 tests per cartridge. Five cartridges per tube (50 tests) | POGO Automatic Test Cartridges | INTUITY MEDICAL, INC. |
5 | 00856176008001 | 00856176008001 | 00856176008001 | Blood Glucose Meter | POGO Automatic Blood Glucose Monitoring System | INTUITY MEDICAL, INC. |
6 | 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. | |
7 | 00854067005238 | EHS-SDMK-V | Smart Diabetes Voice Glucose Monitor | Smart Diabetes | VALUE PROVIDERS LLC | |
8 | 00854067005191 | EHS-SDMK-BT | Smart Diabetes Bluetooth Glucose Monitor | Eocene | VALUE PROVIDERS LLC | |
9 | 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 |
10 | 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 |
11 | 00853553005349 | BG300 | FG02062 | Blood Glucose Meter BG300C | Livongo Blood Glucose Meter | LIVONGO HEALTH, INC |
12 | 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 |
13 | 00853553005301 | Livongo G2.0FW2.1 | KIT00802 | BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish) | Livongo Replacement Device | LIVONGO HEALTH, INC |
14 | 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 |
15 | 00853553005288 | BG300 | FG00688 | Livongo BG300 Blood Glucose Meter | Livongo Blood Glucose Meter | LIVONGO HEALTH, INC |
16 | 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 |
17 | 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 |
18 | 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 |
19 | 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 |
20 | 00853553005196 | BG300 | FG00408 | Livongo BG300 Blood Glucose Meter | Livongo Blood Glucose Meter | LIVONGO HEALTH, INC |
21 | 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 |
22 | 00853553005035 | BG200 | FG00163 | In Touch BG 200 Blood Glucose Meter with Charger Adapter and USB Cable | In Touch Blood Glucose Meter | LIVONGO HEALTH, INC |
23 | 00853553005011 | BG300C, Kaifa DongGuan | FG02062 | BG300 rev C Blood Glucose Meter, Kaifa DongGuan | Livongo Blood Glucose Meter | LIVONGO HEALTH, INC |
24 | 00853483008243 | VGM04 | VivaGuard Ino Smart Blood Glucose Meter | VivaGuard Ino Smart | ABLE DIAGNOSTICS INC | |
25 | 00853483008236 | VGM04 | VGM04-665 | VivaGuard Ino Smart Blood Glucose Meter Only Kit | VivaGuard Ino Smart | ABLE DIAGNOSTICS INC |
26 | 00853483008151 | VGM01 | VivaGuard Ino Blood Glucose Meter | VivaGuard Ino | ABLE DIAGNOSTICS INC | |
27 | 00853483008052 | VGM01 | VGM01-373 | VivaGuard Ino Blood Glucose Meter Only Kit | VivaGuard Ino | ABLE DIAGNOSTICS INC |
28 | 00853483008007 | VGM01 | VGM01-371 | VivaGuard Ino Blood Glucose Monitoring System | VivaGuard Ino | ABLE DIAGNOSTICS INC |
29 | 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. |
30 | 00852668007095 | MGH-BT1 | Blood Glucose meter (label) | MyGlucoHealth® BT Meter | ENTRA HEALTH SYSTEMS LLC | |
31 | 00852668007071 | BLE-SMART-METER | Blood Glucose Meter Label | BLE Smart® Blood Glucose Meter | ENTRA HEALTH SYSTEMS LLC | |
32 | 00852668007064 | BLE-SMART-METER-FDA | Blood Glucose Meter Kit | BLE Smart® Blood Glucose System | ENTRA HEALTH SYSTEMS LLC | |
33 | 00852668007057 | MGH-CL1 | Wireless Blood Glucose Meter | MyGlucoHealth® Wireless Blood Glucose Meter | ENTRA HEALTH SYSTEMS LLC | |
34 | 00852668007040 | MGH-CL1 | Wireless Blood Glucose Meter Kit | MyGlucoHealth® Wireless Blood Glucose System | ENTRA HEALTH SYSTEMS LLC | |
35 | 00851225008001 | 300300 | LucidPlus B-Ketone Plus Blood Glucose Monitoring System | VIDAN DIAGNOSTICS LLC | ||
36 | 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. | |
37 | 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. | |
38 | 00850632007362 | 1 | Blood Glucose Monitor for use with Easy Trak II Testing Strips only | Easy Trak II Blood Glucose Meter | HOME AIDE DIAGNOSTICS, INC. | |
39 | 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. | |
40 | 00850578007044 | GLUCOSE TEST STRIP 50 CT. | HEPRO.US GLUCOSE TEST STRIPS 50units/BX for MM1000 | GLUCOSE TEST STRIP 50 CT. | HEPRO.US INC. | |
41 | 00850081003007 | MGH-BT1 | Blood Glucose Meter Kit | MyGlucoHealth® BT Meter Kit | ENTRA HEALTH SYSTEMS LLC | |
42 | 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 | |
43 | 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 | |
44 | 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 | |
45 | 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 | |
46 | 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 | |
47 | 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 | |
48 | 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 | |
49 | 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 | |
50 | 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 |