No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00357599000356 | 71750 | 71750 | FreeStyle Precision Neo Blood Glucose Test Strips | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Precision Neo | |
2 | 00357599000349 | 71749 | 71749 | FreeStyle Precision Neo Blood Glucose Test Strips | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Precision Neo | |
3 | 00357599000332 | 71748 | 71748 | FreeStyle Precision Neo Blood Glucose Test Strips Not For Retail Sale | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Precision Neo | |
4 | 00357599000301 | 71741 | 71741 | FreeStyle Precision Neo Blood Glucose Monitoring System Not For Retail Sale | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Precision Neo | |
5 | 00093815751755 | 75175 | 75175 | FreeStyle Precision Neo Blood Glucose Monitoring System | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Precision Neo | |
6 | 00093815751700 | 75170 | 75170 | FreeStyle Libre Pro Software | PHV | Continuous glucose monitor retrospective data analysis software | 1 | FreeStyle Libre Pro |
7 | 00093815715818 | 71581 | 71581 | FreeStyle Precision Neo Blood Glucose Test Strips | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Precision Neo | |
8 | 00093815715795 | 71579 | 71579 | FreeStyle Precision Neo Blood Glucose Test Strips | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Precision Neo | |
9 | 00357599000417 | 71760 | 71760 | FreeStyle Libre Pro Reader Kit US DOD | MDS | Sensor, glucose, invasive | FreeStyle Libre Pro | |
10 | 00357599824006 | 72154-01 | 72154-01 | LibreLinkUp | PJT | Continuous glucose monitor secondary display | 2 | LibreLinkUp |
11 | 00357599716875 | 71687 | 71687 | FreeStyle Libre Pro Reader Kit | MDS | Sensor, glucose, invasive | FreeStyle Libre Pro | |
12 | 00357599715625 | 71562 | 71562 | FreeStyle Libre Pro Sensor Kit | MDS | Sensor, glucose, invasive | FreeStyle Libre Pro | |
13 | 00357599715618 | 71561 | 71561 | FreeStyle Libre Pro Sensor Kit | MDS | Sensor, glucose, invasive | FreeStyle Libre Pro | |
14 | 00357599715557 | 71555 | 71555 | FreeStyle Libre Pro Reader Kit | MDS | Sensor, glucose, invasive | FreeStyle Libre Pro | |
15 | 00093815715771 | 71577 | 71577 | FreeStyle Precision Neo Blood Glucose Test Strips | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Precision Neo | |
16 | 00699073000842 | 70851 | 70851 | Abbott Diabetes Care USB Data Cable Software | OUG | Medical device data system | Abbott | |
17 | 00357599000691 | 70901 | 70901 | Abbott SF Single Use Lancing Device | FMK | Lancet, blood | Abbott | |
18 | 00093815000839 | 70845 | 70845 | Abbott Diabetes Care USB Data Cable Software | OUG | Medical device data system | Abbott | |
19 | 00357599819002 | 72080 | 72080 | FreeStyle Libre 3 Sensor Kit NFRS | QLG | Integrated continuous glucose monitoring system, factory calibrated, not for use Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems | FreeStyle Libre 3 | |
20 | 00357599818005 | 72081 | 72081 | FreeStyle Libre 3 Sensor Kit US | QLG | Integrated continuous glucose monitoring system, factory calibrated, not for use Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems | FreeStyle Libre 3 | |
21 | 00699073709011 | 70901 | 70901 | Abbott SF Single Use Lancing Device | FMK | Lancet, blood | 2 | Abbott |
22 | 00699073708519 | 70851 | 70851 | Abbott Diabetes Care USB Data Cable Software | OUG | Medical device data system | 1 | Abbott |
23 | 00357599826000 | 72157-01 | 72157-01 | LibreViewGov | PHV | Continuous glucose monitor retrospective data analysis software | 1 | LibreView Government |
24 | 00093815710653 | 71065 | 71065 | Optium EZ Blood Glucose Monitoring System | NBW,LFR,JJX | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose,SIN SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose,SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | OptiumEZ | |
25 | 00093815710424 | 71042 | 71042 | Optium EZ Blood Glucose Test Strips | LFR,NBW,JJX | Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,SIN Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | OptiumEZ | |
26 | 00093815710417 | 71041 | 71041 | Optium EZ Blood Glucose Test Strips | NBW,JJX,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,SINGLE (SPECIFIED) ANALYTE CONTROL SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),Glucose dehydrogenase, glucose | OptiumEZ | |
27 | 00093815708452 | 70845 | 70845 | Abbott Diabetes Care USB Data Cable Software | OUG | Medical device data system | 1 | Abbott |
28 | 00699073715012 | 71501 | 71501 | FreeStyle Lite Blood Glucose Monitoring System | LFR,NBW | Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Lite | |
29 | 00699073708199 | 70819 | 70819 | FreeStyle Lite Blood Glucose Test Strips | LFR,NBW | Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Lite | |
30 | 00699073708175 | 70817 | 70817 | FreeStyle Lite Blood Glucose Test Strips | LFR,NBW | Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Lite | |
31 | 00699073708052 | 70805 | 70805 | FreeStyle Lite Blood Glucose Monitoring System | LFR,NBW | Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Lite | |
32 | 00699073708045 | 70804 | 70804 | FreeStyle Lite Blood Glucose Monitoring System | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Lite | |
33 | 00357599000479 | 71527 | 71527 | FreeSyle Libre Software CD | PHV | Continuous glucose monitor retrospective data analysis software | 1 | FreeStyle Libre |
34 | 00357599000240 | 71739 | 71739 | FreeStyle Libre Reader Kit US DOD | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre | |
35 | 00357599000202 | 71702 | 71702 | FreeStyle Libre Sensor Kit | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre | |
36 | 00357599000196 | 71536 | 71536 | FreeStyle Libre Sensor Kit | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre | |
37 | 00093815803126 | 80312 | 80312 | MediSense Glucose & Ketone Control Solutions | JJX | Single (specified) analyte controls (assayed and unassayed) | MediSense | |
38 | 00093815801399 | 80139 | 80139 | MediSense Glucose & Ketone Control Solutions | JJX | Single (specified) analyte controls (assayed and unassayed) | MediSense | |
39 | 00357599000226 | 71701 | 71701 | FreeStyle Libre Reader Kit US | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre | |
40 | 00357599000219 | 71525 | 71525 | FreeStyle Libre Reader Kit US | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre | |
41 | 00357599000851 | 71942 | 71942 | FS Libre Sensor Kit | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre | |
42 | 00699073710260 | 71026 | 71026 | FreeStyle Lite Blood Glucose Test Strips | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Lite | |
43 | 00699073708274 | 70827 | 70827 | FreeStyle Lite Blood Glucose Test Strips | LFR,NBW | Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Lite | |
44 | 00699073708229 | 70822 | 70822 | FreeStyle Lite Blood Glucose Test Strips | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Lite | |
45 | 00699073000019 | 70804 | 70804 | FreeStyle Lite Blood Glucose Monitoring System | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | 2 | FreeStyle Lite |
46 | 00357599001025 | 71939 | 71939 | FreeStyle Libre 14 day Sensor Kit NFRS | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre 14 day | |
47 | 00357599002008 | 71938 | 71938 | FreeStyle Libre 14 day Reader Kit US | PZE | Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated | FreeStyle Libre 14 day | |
48 | 00357599001018 | 71940 | 71940 | FreeStyle Libre 14 day Sensor Kit | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre 14 day | |
49 | 00357599000981 | 71936 | 71936 | FreeStyle Libre 14 day Reader Kit US DOD | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre 14 day | |
50 | 00357599000974 | 71937 | 71937 | FreeStyle Libre 14 day Reader Kit US | PZE | Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated | FreeStyle Libre 14 day |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00810038632445 | EZR-101 | EZR-101-50P | Easy@Home Ketone Test Strips (50 Pack) | Easy@Home Ketone Test Strips (50 Pack) | EASY HEALTHCARE CORPORATION |
2 | 00810038631431 | EZR-101 | EZR-101-20(P) | Easy@Home Ketone Test Strips (20 Pack) | Easy@Home Ketone Test Strips (20 Pack) | EASY HEALTHCARE CORPORATION |
3 | 00804084000150 | GCS0104 | For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of b For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of blood glucose test results. The Control Solutions contains a known amount of glucose that reacts with the test strips. | IDEAL LIFE Control Solution Level II | IDEAL LIFE INC | |
4 | 00804084000143 | AGS-1112 | IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips) | IDEAL LIFE INC | ||
5 | 00793150629787 | IGM-1003A | INFS003L | Blood Glucose Test strips | Oh’Care Lite Blood Glucose Test strips | OSANG HEALTHCARE CO., LTD. |
6 | 00793150629787 | IGM-1003A | INFS003L | Blood Glucose Test strips | Oh’Care Lite Blood Glucose Test strips | OSANG HEALTHCARE CO., LTD. |
7 | 00793150629770 | IGM-1003A | INFM003L | Blood Glucose Monitoring System for Self-Testing | Oh’Care Lite Blood Glucose Monitoring System for Self-Testing | OSANG HEALTHCARE CO., LTD. |
8 | 00793150629770 | IGM-1003A | INFM003L | Blood Glucose Monitoring System for Self-Testing | Oh’Care Lite Blood Glucose Monitoring System for Self-Testing | OSANG HEALTHCARE CO., LTD. |
9 | 00793150629763 | IGM-1003A | Blood Glucose Monitoring System Kit | Oh’Care Lite Blood Glucose Monitoring System Kit | OSANG HEALTHCARE CO., LTD. | |
10 | 00793150629763 | IGM-1003A | Blood Glucose Monitoring System Kit | Oh’Care Lite Blood Glucose Monitoring System Kit | OSANG HEALTHCARE CO., LTD. | |
11 | 00763924540105 | MD540 | Lipid and Glucose Measuring System | LipidPlus® Glucose Test Strips | JANT PHARMACAL CORPORATION | |
12 | 00748349000717 | 10001 | 10001 | Glucose Pilot - The Complete Glucose Monitoring System | Glucose Pilot | SYNTRON BIORESEARCH, INC. |
13 | 00739810207742 | TD-4116 | metene BLOOD GLUCOSE MONITORING SYSTEM | METENE LIMITED | ||
14 | 00739810205885 | TD-4116 | metene BLOOD GLUCOSE MONITORING SYSTEM | METENE LIMITED | ||
15 | 00732671009418 | 941 | 941 | Blood Glucose Test Strips | Pip | AMITY HOLDINGS, LLC |
16 | 00725439988933 | TRUE METRIX self monitoring blood glucose meter | RE4097-01 | HEALTHY ACCENTS TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER | TRUE METRIX | TRIVIDIA HEALTH, INC. |
17 | 00725439988933 | TRUE METRIX self monitoring blood glucose meter | RE4097-01 | HEALTHY ACCENTS TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER | TRUE METRIX | TRIVIDIA HEALTH, INC. |
18 | 00722066005255 | U11.1-1S100 | Rapid Response 11 Parameter Urinalysis Reagent Strips (ASC/GLU/BLD/LEU/PRO/NIT/K Rapid Response 11 Parameter Urinalysis Reagent Strips (ASC/GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) - 100 tests/ kit are for qualitative or semi-quantitative determination of Ascorbic Acid, Glucose, Blood, Leukocyte, Protein, Nitrite, Ketone, pH, Bilirubin, Urobilinogen, Specific Gravity in urine. | Rapid Response | BTNX INC | |
19 | 00722066005057 | BG-11L | Gluco-MD Lancets box of 100 lancets | Rapid Response | BTNX INC | |
20 | 00722066004364 | U5.3-1S100 | U5.3-1S100 | Rapid Response 5 Parameter Urinalysis Reagent Strips (KET/PH/PRO/GLU/BLD) – 100 Rapid Response 5 Parameter Urinalysis Reagent Strips (KET/PH/PRO/GLU/BLD) – 100 tests/ kit are for qualitative or semi-quantitative determination of Ketone, pH, Protein, Glucose and Blood in urine. | Rapid Response | BTNX INC |
21 | 00722066003213 | 04GLU-47 | Rapid Response Blood Glucose Lancets | Rapid Response | BTNX INC | |
22 | 00722066003206 | 04GLU-48 | Rapid Response Lancing Device | Rapid Response | BTNX INC | |
23 | 00722066003190 | 04GLU-69NC | Rapid Response Blood Glucose Test Strips | Rapid Response | BTNX INC | |
24 | 00722066003183 | 04GLU-49 | Rapid Response Glucose Controls | Rapid Response | BTNX INC | |
25 | 00722066003176 | 04GLU-67NC | Rapid Response™ Gluco-MD Blood Glucose Meter | Rapid Response | BTNX INC | |
26 | 00722066003022 | U10.1-1S25 | U10.1-1S25 | Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) - 25 tests/ kit are for qualitative or semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine. | Rapid Response | BTNX INC |
27 | 00722066001936 | U120 | Urine Analyzer 120 | Rapid Response | BTNX INC | |
28 | 00722066001219 | UA-500 | Urine Analyzer 500 | Rapid Response | BTNX INC | |
29 | 00722066001172 | U10.1-1S100 | U10.1-1S100 | Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/P Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocyte, Protein, Nitrite, Ketone, pH, Bilirubin, Urobilinogen, Specific Gravity in urine. | Rapid Response | BTNX INC |
30 | 00722066000380 | U7.1-1S100 | U7.1-1S100 | Rapid Response 7 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH Rapid Response 7 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH) - 100 tests/ kit are for qualitative/ semi-quantitative determination of Glucose, Blood, Leukocytes, Protein, Nitrite, Ketone and pH in urine. | Rapid Response | BTNX INC |
31 | 00722066000335 | U-KET-1S100 | U-KET-1S100 | Rapid Response 1 Parameter Urinalysis Reagent Strips (Ketone) - 100 strips/ kit Rapid Response 1 Parameter Urinalysis Reagent Strips (Ketone) - 100 strips/ kit are for the qualitative or semi-quantitative detection of Ketone in urine. | Rapid Response | BTNX INC |
32 | 00713757465007 | TD-4123 | GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM | GENESIS HEALTH TECHNOLOGIES, LLC | ||
33 | 00713757464802 | TD-4123 | GHT Test Strip | GENESIS HEALTH TECHNOLOGIES, LLC | ||
34 | 00713733069816 | TRUE METRIX Self Monitoring Blood Glucose Meter | RE4019-01 | meijer TRUE METRIX Self Monitoring Blood Glucose Meter | TRUE METRIX | TRIVIDIA HEALTH, INC. |
35 | 00713733069816 | TRUE METRIX Self Monitoring Blood Glucose Meter | RE4019-01 | meijer TRUE METRIX Self Monitoring Blood Glucose Meter | TRUE METRIX | TRIVIDIA HEALTH, INC. |
36 | 00708820721098 | TRUE METRIX GO Self Monitoring Blood Glucose Meter | RF4019-01 | Meijer TRUE METRIX GO Self Monitoring Blood Glucose Meter Kit Box | TRUE METRIX GO | TRIVIDIA HEALTH, INC. |
37 | 00708820721098 | TRUE METRIX GO Self Monitoring Blood Glucose Meter | RF4019-01 | Meijer TRUE METRIX GO Self Monitoring Blood Glucose Meter Kit Box | TRUE METRIX GO | TRIVIDIA HEALTH, INC. |
38 | 00708820685659 | TRUE METRIX AIR Self Monitoring Blood Glucose Meter | REA4019-01 | Meijer TRUE METRIX AIR Self Monitoring Blood Glucose Meter Kit | TRUE METRIX AIR | TRIVIDIA HEALTH, INC. |
39 | 00699073715012 | 71501 | 71501 | FreeStyle Lite Blood Glucose Monitoring System | FreeStyle Lite | ABBOTT DIABETES CARE INC |
40 | 00699073715012 | 71501 | 71501 | FreeStyle Lite Blood Glucose Monitoring System | FreeStyle Lite | ABBOTT DIABETES CARE INC |
41 | 00699073714992 | 71499 | 71499 | FreeStyle Freedom Lite Blood Glucose Monitoring System | FreeStyle Freedom Lite | ABBOTT DIABETES CARE INC |
42 | 00699073714992 | 71499 | 71499 | FreeStyle Freedom Lite Blood Glucose Monitoring System | FreeStyle Freedom Lite | ABBOTT DIABETES CARE INC |
43 | 00699073712318 | 71231 | 71231 | FreeStyle InsuLinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |
44 | 00699073712318 | 71231 | 71231 | FreeStyle InsuLinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |
45 | 00699073712301 | 71230 | 71230 | FreeStyle InsuLinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |
46 | 00699073712301 | 71230 | 71230 | FreeStyle InsuLinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |
47 | 00699073712295 | 71229 | 71229 | FreeStyle InsuLinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |
48 | 00699073712295 | 71229 | 71229 | FreeStyle InsuLinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |
49 | 00699073712288 | 71228 | 71228 | FreeStyle Insulinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |
50 | 00699073712288 | 71228 | 71228 | FreeStyle Insulinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |