No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 08809301168073 | GT-C03 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GlucoTrack Solution Level 3 | ||
2 | 08809301161029 | PS-004 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Gmate® Blood Glucose Test Strips | |||
3 | 08809301160411 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate Smart Blood Glucose Monitoring System | ||
4 | 08809301162194 | PC001-US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pip Control Solution Low | ||
5 | 08809301162200 | PC002-US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pip Control Solution Normal | ||
6 | 08809301161036 | PS-004 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Gmate® Blood Glucose Test Strips | |||
7 | 08809301162026 | PC-003 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 3 | ||
8 | 08809301161760 | PS-004 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Pip Blood Glucose Test Strips | |||
9 | 08809301168059 | GT-C01 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GlucoTrack Solution Level 1 | ||
10 | 08809301160152 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
11 | 08809301160114 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
12 | 08809301160015 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
13 | 08809301160862 | PG-310 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | Pip Blood Glucose Monitoring System | ||
14 | 08809301160213 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
15 | 08809301160138 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
16 | 08809301160084 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
17 | 08809301168134 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
18 | 08809301168127 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
19 | 08809301168110 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
20 | 08809301162057 | PC-001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 1 | ||
21 | 08809301162019 | PC-002 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 2 | ||
22 | 08809301168042 | GT-S01 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoTrack Blood Glucose Test Strips | |||
23 | 08809301168011 | GT-S01 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoTrack Blood Glucose Test Strips | |||
24 | 08809301160206 | PG-310 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® Origin Blood Glucose Monitoring System | ||
25 | 08809301160145 | PG-310 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® Origin Blood Glucose Monitoring System | ||
26 | 08809301160077 | PG-310 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® Origin Blood Glucose Monitoring System | ||
27 | 08809301168103 | GT-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack VOICE Blood Glucose Monitoring System | ||
28 | 08809301168097 | GT-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack VOICE Blood Glucose Monitoring System | ||
29 | 08809301168080 | GT-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack Voice Blood Glucose Monitoring System | ||
30 | 08809301166031 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® SMART Blood Glucose Monitoring System | ||
31 | 08809301166017 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® SMART Blood Glucose Monitoring System | ||
32 | 08809301166000 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® SMART Blood Glucose Monitoring System | ||
33 | 08809301162217 | PC003-US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pip Control Solution High | ||
34 | 08809301160169 | PG-201 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® STEP Blood Glucose Monitoring System | ||
35 | 08809301160121 | PG-201 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® STEP Blood Glucose Monitoring System | ||
36 | 08809301160022 | PG-201 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® STEP Blood Glucose Monitoring System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00628063401161 | SK350-QC | SK350-QC | HbA1c Controls | SEKISUI DIAGNOSTICS, LLC | |
2 | 00612479202788 | 5011 | CONTROL KIT, PREG HCG (1/BX) | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
3 | 00605388780065 | 780006 | ReliOn Premier Control Solution Level 2 contains a known amount of glucose that ReliOn Premier Control Solution Level 2 contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 605388780065 is used as the assigned UDI for the Class I device.) | ReliOn™ Premier Control Solution Level 2 | WAL-MART STORES, INC. | |
4 | 00605388780058 | 780005 | ReliOn Premier Control Solution Level 1 contains a known amount of glucose that ReliOn Premier Control Solution Level 1 contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 605388780058 is used as the assigned UDI for the Class I device.) | ReliOn™ Premier Control Solution Level 1 | WAL-MART STORES, INC. | |
5 | 00605388710055 | 710005 | ReliOn Confirm/Micro Control contains a known amount of glucose that reacts with ReliOn Confirm/Micro Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly. Compare the control solution test result with the range printed on the test strip bottle. | ReliOn™ Confirm/Micro Control | WAL-MART STORES, INC. | |
6 | 00389167362108 | 036210 | 036210 | UniStrip Control Solution Low 4mL | UniStrip Control Solution Low | UNISTRIP TECHNOLOGIES, LLC |
7 | 00389154000693 | 3L-10-16003F | 3L-10-16003F | GL GoodLife Blood Glucose Test Strip(Content:50 strips and 50 lancet.) | GL GoodLife AC11-Strip(foil) | HMD BIOMEDICAL INC. |
8 | 00389154000679 | 3K-01-16003S | 3K-01-16003S | GL GoodLife Blood Glucose Meter (single patient home use) | GL GoodLife Blood Glucose Meter AC-11 | HMD BIOMEDICAL INC. |
9 | 00389154000631 | AC-11 AC302 | 3K-01-16003R | GL GoodLife AC-302 Blood Glucose Meter (include GCS ),Standard type. | GL GoodLife AC-302 Blood Glucose Monitoring System | HMD BIOMEDICAL INC. |
10 | 00389154000570 | AC-11 vial | 3S-01-16003C | GL GoodLife AC300 Blood Glucose Test Strip | GL GoodLife AC300 Test Strip-Vial | HMD BIOMEDICAL INC. |
11 | 00389154000549 | 3C-01-160032 | 3C-01-160032 | GL GoodLife Glucose Control Solution | GL GoodLife Glucose Control Solutions | HMD BIOMEDICAL INC. |
12 | 00389154000440 | GL GCS | 3C-01-810032 | GL GoodLife Glucose Control Solution(Level 1) for use with GL GoodLife Blood Glu GL GoodLife Glucose Control Solution(Level 1) for use with GL GoodLife Blood Glucose System | GL GoodLife Glucose Control Solution(Level 1) | HMD BIOMEDICAL INC. |
13 | 00389154000389 | AC11 | 3K-01-16003H | Rosie SmartMeter Blood Glucose Monitoring System | Rosie SmartMeter | HMD BIOMEDICAL INC. |
14 | 00389154000372 | IG01 | 3K-01-810037 | GL GoodLife Blood Glucose Monitoring System(Cloudia) | GL GoodLife | HMD BIOMEDICAL INC. |
15 | 00389154000266 | IG STRIP FOIL | 3L-10-810037 | GL GoodLife Blood Glucose Test Strip-Foil For Cloudia | GL GoodLife Blood Glucose Test Strip-Foil For Cloudia | HMD BIOMEDICAL INC. |
16 | 00389154000204 | 3L-10-16003A | 3L-10-16003A | GL GoodLife Blood Glucose Test Strip(Foil) | GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil) | HMD BIOMEDICAL INC. |
17 | 00389154000075 | AC11-Foil | 3K-01-16003C | GoodLife AC Blood Glucose Test Strips | GL GoodLife Blood Glucose Test Strip AC (50ct in foil) | HMD BIOMEDICAL INC. |
18 | 00386100001933 | 10799 | 10799 | CRP Quality Control Kit Level 3 for use with EasyRA Analyzer | CRP Quality Control Kit Level 3 | MEDICA CORPORATION |
19 | 00386100001926 | 10798 | 10798 | CRP Quality Control Kit Level 2 for use with EasyRA Analyzer | CRP Quality Control Kit Level 2 | MEDICA CORPORATION |
20 | 00386100001919 | 10797 | 10797 | CRP Quality Control Kit Level 1 for use with EasyRA Analyzer | CRP Quality Control Kit Level 1 | MEDICA CORPORATION |
21 | 00386100001902 | 10796 | 10796 | HbA1c Quality Control Kit Level 2 for use with EasyRA Analyzer | HbA1c Quality Control Kit Level 2 | MEDICA CORPORATION |
22 | 00386100001896 | 10795 | 10795 | HbA1c Quality Control Kit Level 1 for use with EasyRA Analyzer | HbA1c Quality Control Kit Level 1 | MEDICA CORPORATION |
23 | 00385543764023 | 8000-03764 | Control Solution, AgaMatrix, Combo Normal and High | AgaMatrix | AGAMATRIX, INC. | |
24 | 00385480547901 | 1.86 | 54790 | Statstrip Glucose Meter with Battery and Quick Reference Guide | STATSTRIP | NOVA BIOMEDICAL CORPORATION |
25 | 00385480536653 | PRIME ABG | 53665 | Remanufactured Prime ABG w/ Scanner Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
26 | 00385480536554 | PRIME ABG | 53655 | Prime ABG w/ Scanner Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
27 | 00385480534215 | PRIME ABG | 53421 | Remanufactured PRIME ABG Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
28 | 00385480528559 | PRIME ABG | 52855 | Prime ABG w/ Scanner Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
29 | 00385480517072 | 1.0 | 51707 | StatStrip GLU Meter with Quick Reference Guide Remanufactured | STATSTRIP | NOVA BIOMEDICAL CORPORATION |
30 | 00385480475549 | STATSTRIP LAC | 47554 | Nova StatStrip LAC Control, Level 2 | NOVA | NOVA BIOMEDICAL CORPORATION |
31 | 00385480475532 | STATSTRIP LAC | 47553 | Nova StatStrip LAC Control, Level 1 | NOVA | NOVA BIOMEDICAL CORPORATION |
32 | 00385480471435 | 1.0 | 47143 | StatStrip Glu Meter and Quick Reference Guide Remanufactured | STATSTRIP | NOVA BIOMEDICAL CORPORATION |
33 | 00385480467995 | Ejector | 46799 | StatStrip Xpress GLU Meter with Battery and Quick Reference Guide | STATSTRIP | NOVA BIOMEDICAL CORPORATION |
34 | 00385480458863 | 1.0 | 45886 | StatStrip GLU Meter with Quick Reference Guide Remanufactured | STATSTRIP | NOVA BIOMEDICAL CORPORATION |
35 | 00385480458245 | Plus | 45824 | Nova Max Plus Blood Glucose Monitoring System | Nova Max | NOVA BIOMEDICAL CORPORATION |
36 | 00385480440370 | Creatinine | 44037 | StatSensor Creat Linearity Level 1 - 5 | StatSensor | NOVA BIOMEDICAL CORPORATION |
37 | 00385480439237 | 1.0 | 43923 | StatSensor Creat Control Level 3 | STATSENSOR | NOVA BIOMEDICAL CORPORATION |
38 | 00385480439220 | 1.0 | 43922 | StatSensor Creat Control Level 2 | STATSENSOR | NOVA BIOMEDICAL CORPORATION |
39 | 00385480439213 | 1.0 | 43921 | StatSensor Creat Control Level 1 | STATSENSOR | NOVA BIOMEDICAL CORPORATION |
40 | 00385480437738 | 1.0 | 43773 | StatStrip GLU Meter and Quick Reference Guide Remanufactured | StatStrip | NOVA BIOMEDICAL CORPORATION |
41 | 00385480434461 | GLU | 43446 | Nova Max Glucose Normal Glucose Control Solution | NOVA MAX | NOVA BIOMEDICAL CORPORATION |
42 | 00385480434362 | Plus | 43436 | Nova Max Plus Blood Glucose Monitoring System | Nova Max | NOVA BIOMEDICAL CORPORATION |
43 | 00385480434355 | Plus | 43435 | Nova Max Plus Plus Blood Glucose Monitoring System | Nova Max | NOVA BIOMEDICAL CORPORATION |
44 | 00385480421737 | Statstrip/StatStrip Xpress | 42173 | StatStrip StatStrip Xpress GLU Linearity Level 1-5 | StatStrip | NOVA BIOMEDICAL CORPORATION |
45 | 00385480417433 | STATSTRIP XPRESS GLU | 41743 | StatStrip StatStrip Xpress GLU Control Level 3 | NOVA | NOVA BIOMEDICAL CORPORATION |
46 | 00385480417426 | STATSTRIP XPRESS GLU | 41742 | StatStrip StatStrip Xpress GLU Control Level 2 | NOVA | NOVA BIOMEDICAL CORPORATION |
47 | 00385480417419 | STATSTRIP XPRESS GLU | 41741 | StatStrip StatStrip Xpress GLU Control Level 1 | NOVA | NOVA BIOMEDICAL CORPORATION |
48 | 00384849903105 | 990310 | 990310 | Prodigy Control Solution Low 4mL | Prodigy Control Solution Low | PRODIGY DIABETES CARE, LLC |
49 | 00384840719507 | 071950 | 071950 | Prodigy Voice Blood Glucose Monitoring System (KIT) | Prodigy Voice Blood Glucose Monitoring System | PRODIGY DIABETES CARE, LLC |
50 | 00384840533509 | 053350 | 053350 | Prodigy Control Solution High 4mL | Prodigy Control Solution High | PRODIGY DIABETES CARE, LLC |