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 | 10732671108040 | 804 | 804 | Safety Lancet | ReadyLance | AMITY HOLDINGS, LLC |
2 | 10732671180619 | 8061 | 8061 | Safety Lancet | NovaPlus | AMITY HOLDINGS, LLC |
3 | 10732671180510 | 8051 | 8051 | Safety Lancet | NovaPlus | AMITY HOLDINGS, LLC |
4 | 10732671180411 | 8041 | 8041 | Safety Lancet | NovaPlus | AMITY HOLDINGS, LLC |
5 | 10732671180312 | 8031 | 8031 | Safety Lancet | NovaPlus | AMITY HOLDINGS, LLC |
6 | 10732671180213 | 8021 | 8021 | Safety Lancet | NovaPlus | AMITY HOLDINGS, LLC |
7 | 10732671120059 | 2005 | 2005 | Button Activated Safety Heelstick Lancet | MediHeel | AMITY HOLDINGS, LLC |
8 | 10732671120042 | 2004 | 2004 | Button-Activated Safety Heelstick Lancet | MediHeel | AMITY HOLDINGS, LLC |
9 | 10732671110067 | 1006 | 1006 | Pressure Activated Safety Heel-Stick Lancet | MediHeel | AMITY HOLDINGS, LLC |
10 | 10732671110036 | 1003 | 1003 | Pressure Activated Safety Heel-stick Lancet | MediHeel | AMITY HOLDINGS, LLC |
11 | 10732671109030 | 903 | 903 | Safety Lancet | PIP | AMITY HOLDINGS, LLC |
12 | 10732671109023 | 902 | 902 | Safety Lancet | Pip | AMITY HOLDINGS, LLC |
13 | 10732671109016 | 901 | 901 | Safety Lancet | PIP | AMITY HOLDINGS, LLC |
14 | 10732671108163 | 816 | 816 | Safety Lancet | ReadyLance | AMITY HOLDINGS, LLC |
15 | 10732671108095 | 809 | 809 | Safety Lancet | ReadyLance | AMITY HOLDINGS, LLC |
16 | 10732671100518 | 10051 | 10051 | Pressure Activated Safety Heel-Stick Lancet | NovaPlus | AMITY HOLDINGS, LLC |
17 | 10732671100419 | 10041 | 10041 | Pressure Activated Safety Heel-Stick Lancet | NovaPlus | AMITY HOLDINGS, LLC |
18 | 10612479223391 | 16-PAHL2.5G1.0 | Heel Incision Device NEWBORN STERILE -SAFETY LANCETS 1 mm Incision Depth x 2.5 m Heel Incision Device NEWBORN STERILE -SAFETY LANCETS 1 mm Incision Depth x 2.5 mm Incision Length | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
19 | 10304040028992 | 9007980 | 9007980 | Lancet Safety Press Act Orange | Henry Schein | HENRY SCHEIN, INC. |
20 | 10304040059804 | 5700675 | 5700675 | Lancet Safety Press Activated | Henry Schein | HENRY SCHEIN, INC. |
21 | 10304040059798 | 5700676 | 5700676 | Lancet Safety Press Activated | Henry Schein | HENRY SCHEIN, INC. |
22 | 10304040059781 | 5700674 | 5700674 | Lancet Safety Press Activated | Henry Schein | HENRY SCHEIN, INC. |
23 | 10304040029067 | 9007993 | 9007993 | Safety Lancet Press Act Green | Henry Schein | HENRY SCHEIN, INC. |
24 | 10304040029050 | 9007992 | 9007992 | Lancet Safety Press Act LtBlue | Henry Schein | HENRY SCHEIN, INC. |
25 | 10304040029043 | 9007991 | 9007991 | Lancet Safety Press Act Purple | Henry Schein | HENRY SCHEIN, INC. |
26 | 10304040029036 | 9007983 | 9007983 | Lancet Safety Press Act Yellow | Henry Schein | HENRY SCHEIN, INC. |
27 | 10304040029029 | 9007982 | 9007982 | Lancet Safety Press Act Rose | Henry Schein | HENRY SCHEIN, INC. |
28 | 10304040029012 | 9007981 | 9007981 | Lancet Safety Press Act Gray | Henry Schein | HENRY SCHEIN, INC. |
29 | 08887629000312 | SC-250 | Lancets are used to make punctures to obtain small blood specimens, are generall Lancets are used to make punctures to obtain small blood specimens, are generally disposable, and are commonly used by diabetes patient. the small blood samples obtained cab be tested for blood glucose, hemoglobin, and many other blood components. lancets are also used prick the skin in skin testing for allergies | SAFETICET | NSP TECH PTE LTD | |
30 | 08887629000213 | SC-220 | Lancets are used to make punctures to obtain small blood specimens, aregenerally Lancets are used to make punctures to obtain small blood specimens, aregenerally disposable, and are commonly used by diabetes patient. The smallblood samples obtained can be tested for blood glucose, hemoglobin, andmany other blood components. Lancets are also used to prick the skin in skintesting for allergies. | SAFETICET | NSP TECH PTE LTD | |
31 | 08887629000114 | SC-180 | Lancets are used to make punctures to obtain small blood specimens, are generall Lancets are used to make punctures to obtain small blood specimens, are generally disposable, and are commonly used by diabetes patient. the small blood samples can be tested for blood glucose, hemoglobin, and many other blood components. lancets are also used to prick the skin in skin testing for allergies. | SAFETICET | NSP TECH PTE LTD | |
32 | 08887629000015 | SC-150 | Lancets are used to make punctures to obtain small blood specimens, are generall Lancets are used to make punctures to obtain small blood specimens, are generally disposable, and are commonly used by diabetes patient. the small blood samples obtained can be tested for blood glucose, hemoglobin, and many other blood components. lancets are also used to prick the skin in skin testing for allergies. | SAFETICET | NSP TECH PTE LTD | |
33 | M220P9290283 | P929028 | P929028 | Pro Advantage 28G micro flow safety lancet green 200/BX | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
34 | M220P9290253 | P929025 | P929025 | Pro Advantage 25G low flow safety lancet purple 200/BX | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
35 | M220P9290213 | P929021 | P929021 | Pro Advantage 21G normal flow safety lancet blue 200/BX | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
36 | 06971292001430 | TS1111011 | The Draw-In blood glucose test strip is designed to provide an easy, accurate me The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
37 | 06971292001287 | TS1500011 | The Draw-In blood glucose test strip is designed to provide an easy, accurate me The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
38 | 06971292001256 | TS1150011 | The Draw-In blood glucose test strip is designed to provide an easy, accurate me The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
39 | 06971292001188 | TS1111 | The Draw-In blood glucose test strip is designed to provide an easy, accurate me The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
40 | 06971292001140 | TS1111011 | The Draw-In blood glucose test strip is designed to provide an easy, accurate me The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
41 | 06971227404923 | HB-100 | Microdot | PROMISEMED HANGZHOU MEDITECH CO., LTD. | ||
42 | 06971227404916 | HB-085 | Microdot | PROMISEMED HANGZHOU MEDITECH CO., LTD. | ||
43 | 06949517003460 | LF-PA-21B | Pressure Activated Safety Lancet (Bag of 25 lancets), radiation (gamma) sterilization | Safety Lancet (21GBlade) | SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO.,LTD | |
44 | 06949517003453 | LF-PA-21B | Pressure Activated Safety Lancet (Bag of 10 lancets), radiation (gamma) sterilization | Safety Lancet (21GBlade) | SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO.,LTD | |
45 | 06949517003446 | LF-PA-18B | Pressure Activated Safety Lancet (Box of 200 lancets), radiation (gamma) sterilization | Safety Lancet (18GBlade) | SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO.,LTD | |
46 | 06949517003422 | LF-PA-18B | Pressure Activated Safety Lancet (Box of 100 lancets), radiation (gamma) sterilization | Safety Lancet (18GBlade) | SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO.,LTD | |
47 | 06949517003415 | LF-PA-18B | Pressure Activated Safety Lancet (Bag of 100 lancets), radiation (gamma) sterilization | Safety Lancet (18GBlade) | SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO.,LTD | |
48 | 06949517003408 | LF-PA-18B | Pressure Activated Safety Lancet (Box of 50 lancets), radiation (gamma) sterilization | Safety Lancet (18GBlade) | SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO.,LTD | |
49 | 06949517003392 | LF-PA-18B | Pressure Activated Safety Lancet (Bag of 50 lancets), radiation (gamma) sterilization | Safety Lancet (18GBlade) | SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO.,LTD | |
50 | 06949517003385 | LF-PA-18B | Pressure Activated Safety Lancet (Box of 25 lancets), radiation (gamma) sterilization | Safety Lancet (18GBlade) | SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO.,LTD |