No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00885017000560 | EM44 | a bottle of level 2 control solution | NBW | System, Test, Blood Glucose, Over The Counter | 2 | EasyMax 15 NHCS Set EN | |
2 | 00885017000287 | EASY MAX 15 | The EASY MAX 15 Glucose Test Strips are intended for the quantitative measuremen The EASY MAX 15 Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. The test Strips must be used with the EASY MAX 15 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, is not for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions. | NBW | System, Test, Blood Glucose, Over The Counter | 2 | 25 EasyMax 15 FTS Set EN-ES | |
3 | 00885017000553 | EasyMax | 1 bottle of Level 2 Solution | NBW | System, Test, Blood Glucose, Over The Counter | 2 | EasyMax NHCS Set EN | |
4 | 00885017000362 | EM44 | a bottle of level 1 control solution | NBW | System, Test, Blood Glucose, Over The Counter | EM 15 Blood Glucose Level 1 Control Solution | ||
5 | 00885017000584 | EM44 | a bottle of level 1 and a bottle of level 2 control solution | NBW | System, Test, Blood Glucose, Over The Counter | EM 15 Blood Glucose Level 1 and Level 2 Control Solution | ||
6 | 00885017000416 | EM44 | 50 strips in a vial | NBW | System, Test, Blood Glucose, Over The Counter | EasyMax 15 Blood Glucose Test Strip | ||
7 | 00885017000324 | EMMU | 1 blood glucose meter; 10 strips in a vial; level 2 control solution, 10 lancets 1 blood glucose meter; 10 strips in a vial; level 2 control solution, 10 lancets, 1 lancing device in a convenience kit.1 blood glucose meter; 10 strips in a vial; level 2 control solution, 5 lancets, 1 lancing device in a convenience kit. (10885017000321) | NBW | System, Test, Blood Glucose, Over The Counter | EasyMax NG Self-Monitoring Blood Glucose System | ||
8 | 00885017000270 | EASY MAX | The EASY MAX Glucose Test Strips are intended for the quantitative measurement o The EASY MAX Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. The EASY MAX Glucose Test Strips must be used with the EASY MAX Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. | NBW | System, Test, Blood Glucose, Over The Counter | 2 | 25 EasyMax FTS Set EN-ES | |
9 | 00885017000171 | EM44 | 10 strips in a vial | NBW | System, Test, Blood Glucose, Over The Counter | 2 | EasyMax 15 Blood Glucose Test Strip | |
10 | 00885017000065 | EMMU | Semi kit: one blood glucose meter | NBW | System, Test, Blood Glucose, Over The Counter | EasyMax NG Self-Monitoring Blood Glucose System | ||
11 | 00885017000102 | EMMU | Semi kit: one blood glucose meter | NBW | System, Test, Blood Glucose, Over The Counter | EasyMax LTC Self-Monitoring Blood Glucose System | ||
12 | 00885017000638 | EM44 | a bottle of level 2 control solution | NBW | System, Test, Blood Glucose, Over The Counter | 2 | EM 15 Blood Glucose Level 2 Control Solution | |
13 | 00885017000461 | EM66 | 1 blood glucose meter; 10 strips in a vial; level 2 control solution in a convenience kit | NBW | System, Test, Blood Glucose, Over The Counter | FortisCare Self-Monitoring Blood Glucose System | ||
14 | 00885017000300 | EasyMax T1 Pro | 1 blood glucose meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | FortisCare Self-Monitoring Blood Glucose System | |
15 | 00885017000058 | EMV | one blood glucose meter | NBW | System, Test, Blood Glucose, Over The Counter | EasyMax V Self-Monitoring Blood Glucose System | ||
16 | 00885017000591 | EasyMax | 1 bottle of Level 2 Control Solution | NBW | System, Test, Blood Glucose, Over The Counter | EasyMax Blood Glucose Level 2 Control Solution | ||
17 | 00885017000447 | EM44 | 50 strips in a vial | NBW | System, Test, Blood Glucose, Over The Counter | FortisCare Blood Glucose Test Strip | ||
18 | 00885017000355 | EasyMax | 10 strips in a vial | NBW | System, Test, Blood Glucose, Over The Counter | EasyMax Blood Glucose Test Strip | ||
19 | 00885017000317 | EasyMax T1 Pro | 50 strips in a vial | NBW | System, Test, Blood Glucose, Over The Counter | 2 | FortisCare Blood Glucose Test Strip | |
20 | 00885017000263 | EasyMax G1 FTS | 25 strips in a vial. | NBW | System, Test, Blood Glucose, Over The Counter | 2 | FortisCare Blood Glucose Test Strip |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00875011000307 | 0030 | 0030 Omada BGM- RPM | Greater Goods | GREATER GOODS | |
2 | 00868665000076 | 3S-01-16003A | 3S-01-16003A | Rosie SmartMeter Blood Glucose GDH-FAD Test Strips | Rosie SmartMeter Test Strips 50ct(vial) | HMD BIOMEDICAL INC. |
3 | 00868665000069 | 3C-01-160033 | 3C-01-160033 | Rosie SmartMeter glucose control solution | Rosie SmartMeter Glucose Control Solutions | HMD BIOMEDICAL INC. |
4 | 00868665000052 | AC-11 Pro-Strip | 3L-10-16003E | Rosie SmartMeter Professional Strip-Foil | Rosie SmartMeter Professional Strip | HMD BIOMEDICAL INC. |
5 | 00868665000045 | AC-NFC Meter | 3K-01-16003K | Rosie SmartMeter NFC Professional Blood Glucose Meter | Rosie SmartMeter NFC Professional | HMD BIOMEDICAL INC. |
6 | 00866457000303 | MD6 | Multi-Functional Monitoring System | Bruno | BRUNO PHARMA INNOVATIONS, LLC | |
7 | 00863398000294 | G-427B | Blood glucose meter. | Scan | LEXINGTON WELLNESS HOLDINGS INC. | |
8 | 00861700000321 | PWR-08-09 | Glucose meter accessory providing Bluetooth connectivity to glucose meters manuf Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Abbott. Specific meters supported are FreeStyle Lite and FreeStyle Freedom Lite | Polytel GMA | POLYMAP WIRELESS | |
9 | 00861700000314 | PWR-08-07 | Glucose meter accessory providing Bluetooth connectivity to glucose meters manuf Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Bayer. Specific meters supported are Breeze2, Contour, Contour TS, Contour next EZ. | Polytel GMA | POLYMAP WIRELESS | |
10 | 00861700000307 | PWR-08-06 | Glucose meter accessory providing Bluetooth connectivity to glucose meters manuf Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by LifeScan Inc. Specific meters supported are OneTouch Ultra, OneTouch Ultra2, OneTouch UltraMini, OneTouch UltraEasy | Polytel GMA | POLYMAP WIRELESS | |
11 | 00860421000498 | TD-4142 | POPS! one Blood Glucose Monitoring System | POPS! DIABETES CARE, INC. | ||
12 | 00860418002610 | 8000-10635 | Blood Glucose Monitoring System, Choice | Choice | ARCADIA GROUP | |
13 | 00860418002603 | 8000-10634 | Blood Glucose Monitoring System, Choice Basic | Choice | ARCADIA GROUP | |
14 | 00860396000615 | IGM-1003A | INFS003L | Blood Glucose Test strips | Oh’Care Lite Blood Glucose Test strips | IJDREAM CORPORATION |
15 | 00860396000608 | ijCare Blood Glucose Monitoring System Kit | ijCare | IJDREAM CORPORATION | ||
16 | 00860394001294 | CURO Glucose Strips | CURO Glucose Strips for G6 and G6s | CURO Glucose Strips | KPI HEALTHCARE, INC. | |
17 | 00860394001263 | CURO G6 Glucose Meter | CURO G6 Glucose Meter | CURO G6 Glucose Meter | KPI HEALTHCARE, INC. | |
18 | 00860394001256 | CURO L5 Total Cholesterol Strips | Total Cholesterol Strips | CURO L5 Total Cholesterol Strips | KPI HEALTHCARE, INC. | |
19 | 00860394001249 | CURO G6s Smart Glucose Meter | CURO G6s Smart Glucose Meter | CURO G6s Smart Glucose Meter | KPI HEALTHCARE, INC. | |
20 | 00860394001225 | CURO L5 CURO L5 | CURO L5 Cholesterol and Glucose measuring system | CURO L5 | KPI HEALTHCARE, INC. | |
21 | 00860313000919 | IGM-1003A | INFM003L | Blood Glucose Monitoring System for Self-Testing | Oh’Care Lite Blood Glucose Monitoring System for Self-Testing | IJDREAM CORPORATION |
22 | 00860167002503 | MED-OW-A100-KIT-50 | Blood Glucose Testing Kit with 50 Refills | Owell | O'WELL | |
23 | 00860008115959 | TE-GLU-A1 | Bluetooth Blood Glucose Monitor | Tenovi | TENOVI CO. | |
24 | 00860008115942 | TE-CTR-P1 | Glucometer Control Solution - A/B Pack | Tenovi | TENOVI CO. | |
25 | 00860008115935 | TE-CTR-B1 | Glucometer Control Solution - B | Tenovi | TENOVI CO. | |
26 | 00860008115928 | TE-CTR-A1 | Glucometer Control Solution | Tenovi | TENOVI CO. | |
27 | 00860008115911 | TE-STR-A1 | Glucometer Test Strips | Tenovi | TENOVI CO. | |
28 | 00860008115904 | TE-KIT-A1 | Bluetooth Blood Glucose Monitoring System | Tenovi | TENOVI CO. | |
29 | 00860005745944 | TD-4279 | bkt ß-Ketone & blood glucose monitoring system | ADAM LAWRENCE | ||
30 | 00860005745920 | TD-4279 | bkt Blood Glucose Test Strips (50pcs/box) | ADAM LAWRENCE | ||
31 | 00860005745906 | TD-4279 | bkt ß-Ketone Test Strips (100 pcs/box) | ADAM LAWRENCE | ||
32 | 00860003222324 | TD-4140 | Center Health Smart Lightning dongle Blood Glucose Monitoring System | CENTER HEALTH INCORPORATED | ||
33 | 00860003222300 | TD-4140 | Center Health Nano Smart Dongle Blood Glucose Monitoring System | CENTER HEALTH INCORPORATED | ||
34 | 00859811007681 | BGTS50-24/0768 | Glucose Test Strip | NuvoMed | NUVOMED, INC. | |
35 | 00859811007414 | MBG10-6/0741 | Blood Glucose with 10 Strips (Non-apps) | Nuvomed | NUVOMED, INC. | |
36 | 00859811007261 | NGS50-24/0726 | Glucose Test Strip (Non-apps) | NuvoMed | NUVOMED, INC. | |
37 | 00859811007063 | BGTS50-24/0768 | Glucose test strip | NuvoMed | NUVOMED, INC. | |
38 | 00859811007049 | BGM-6/0352 | Wireless Blood Glucose Monitoring System | NuvoMed | NUVOMED, INC. | |
39 | 00859519002407 | TM0009 | TM0009 | BioTel Care BGM 4 | BioTel Care BGM 4 | TELCARE, LLC |
40 | 00859519002223 | BGM | TM0008 | The BioTel Care® Blood Glucose Monitoring System consists of a meter, test strip The BioTel Care® Blood Glucose Monitoring System consists of a meter, test strips, and control solutions (Level 1 and Level 2). The BioTel Care® Blood Glucose Meter, when used with the BioTel Care® Blood Glucose Test Strip, quantitatively measures glucose in capillary whole blood. The BioTel Care® Glucose Control Solutions are used by patients to verify the performance of the BioTel Care® test strips and BioTel Care® meter. | BioTel Care® Blood Glucose Monitoring System | TELCARE, LLC |
41 | 00859519002056 | CS | TC0003 | Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips. | BioTel Care® Double Control Solution | TELCARE, LLC |
42 | 00859519002018 | TS | TT0003 | Test strips for use with BioTel Care® Blood Glucose Meter and BioTel Care® Contr Test strips for use with BioTel Care® Blood Glucose Meter and BioTel Care® Control Solution. | BioTel Care® Test Strips | TELCARE, LLC |
43 | 00859509006064 | 8000-10584 | System Kit, Blood Glucose Meter, One Drop, mg/dL, (25ct) | One Drop | INFORMED DATA SYSTEMS INC. | |
44 | 00859509006033 | 8000-10510 | Test Strips, One Drop, 50ct | One Drop | INFORMED DATA SYSTEMS INC. | |
45 | 00859509006026 | 8000-10495 | System Kit, Blood Glucose Meter, One Drop, mgd/L | One Drop | INFORMED DATA SYSTEMS INC. | |
46 | 00859509006019 | 8000-10465 | Blood Glucose Meter, One Drop, mg/dL | One Drop | INFORMED DATA SYSTEMS INC. | |
47 | 00858538007301 | TD-4279 | keto mojo glucose test strips (50pcs/box) | KETO-CHECK, INC. | ||
48 | 00858538007202 | TD-4279 | Keto-mojo β-ketone test strips (10pcs/box) | KETO-CHECK, INC. | ||
49 | 00858538007127 | TD-4279 | Glucose Test strip 10 PCSKetone Test strip 10 PCSLancing device 1 PCSLancet 10PCS | bkt ß-Ketone & blood glucose monitoring system | ADAM LAWRENCE | |
50 | 00858538007103 | TD-4279 | keto mojo β-ketone & blood glucose monitoring system | KETO-CHECK, INC. |