No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00365702702684 | 09397116001 | 09397116001 | IWL Lancets 10ct | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 2 | Instant White Label |
2 | 00365702107106 | 04528638001 | ACCU-CHEK AVIVA 2 LEVEL CONTROL 6/CS | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | ACCU-CHEK Aviva | ||
3 | 00365702710108 | 07453710001 | Accu-Chek Guide 25ct Strip 36/cs | LFR | Glucose Dehydrogenase, Glucose | 2 | Accu-Chek Guide | |
4 | 00365702702660 | 09556672001 | 09556672001 | Relion Platinum Lancing Device | QRL | Multiple Use Blood Lancet For Single Patient Use Only | 2 | RELION |
5 | 00365702702431 | 08387052001 | ACCU-CHEK GUIDE ME MG/DL METER 897 (US) | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Accu-Chek Guide | |
6 | 00365702726109 | 08053723001 | Accu-Chek Guide Mail Order 50 ct | LFR | Glucose Dehydrogenase, Glucose | 2 | Accu-Chek Guide | |
7 | 00365702719101 | 08256292001 | Accu-Chek Guide 50ct HN 36/cs | LFR | Glucose Dehydrogenase, Glucose | 2 | Accu-Chek Guide | |
8 | 00365702729100 | 08453071001 | Accu-Chek Guide Retail Kit FCN mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | Accu-Chek Guide | ||
9 | 00365702728103 | 08453063001 | Accu-Chek Guide Sample Kit FCN mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Accu-Chek Guide | |
10 | 00365702609105 | 07398794001 | ACCU-CHEK GUIDE MG/DL METER 923 (US) | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Accu-Chek Guide | |
11 | 00365702508101 | 06604765001 | 06604765001 | ACCU-CHEK 360 INSULIN PUMP CONFIG SW US | MRZ | Accessories, Pump, Infusion | 2 | ACCU-CHEK 360 |
12 | 00365702457102 | 05959551001 | 05959551001 | ACCU-CHEK PERFORMA PROF METER KIT US F2 | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK PERFORMA |
13 | 00365702702394 | 08340331001 | ACCU-CHEK AVIVA MG/DL 455 US NON-VA | LFR | Glucose Dehydrogenase, Glucose | 2 | Accu-Chek Aviva | |
14 | 00365702723108 | 08350051001 | Accu-Chek Aviva Plus Retail Kit 10/case | NBW | System, Test, Blood Glucose, Over The Counter | Accu-Chek Aviva | ||
15 | 00365702897106 | 03789721001 | 03789721001 | Accu-Chek Softclix Mailorder 100ct 12/cs | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Accu-Chek Softclix | |
16 | 00365702700123 | 09275371001 | 09275371001 | Accu-Chek Softclix AST Kit USA | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Accu-Chek Softclix | |
17 | 00365702400108 | 05509661001 | 05509661001 | Accu-Chek Softclix (black) USA 12/case | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Accu-Chek Softclix | |
18 | 00365702156104 | 04980263001 | 04980263001 | Accu-Chek Softclix HN Lancets 100ct 12cs | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Accu-Chek Softclix | |
19 | 00075537009710 | 11893238160 | 11893238160 | Accu-Chek Softclix Lancets 100ct 12/cs | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Accu-Chek Softclix | |
20 | 04015630084937 | 03144844001 | 03144844001 | Accu-Chek Softclix Lancets 10/pk | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 2 | Accu-Chek Softclix |
21 | 04015630082209 | 05181186001 | 05181186001 | Accu-Chek Softclix Black Bulk 100 | QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 2 | Accu-Chek Softclix |
22 | 00365702700932 | 06908420002 | VIAL LBLD 10CT STRIP AC AVIVA PLUS BRK | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS | |
23 | 00365702712102 | 07453744001 | 07453744001 | ACCU-CHEK GUIDE 100CT STRIP 24/CS | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK GUIDE | |
24 | 00365702701236 | 06444393001 | Accu-Chek Compact Plus Control L2 (Bio)The UDI information was not placed on the Accu-Chek Compact Plus Control L2 (Bio)The UDI information was not placed on the vial label due to the new kit guidance that was published. | LFR | Glucose Dehydrogenase, Glucose | 2 | Accu-Chek Compact Plus | |
25 | 00365702733107 | 08499918001 | Accu-Chek Guide Me Smpl Kit FC mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Accu-Chek Guide Me | |
26 | 00365702732100 | 08499900001 | Accu-Chek Guide Me Meter Only mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Accu-Chek Guide Me | |
27 | 00365702731103 | 08499896001 | Accu-Chek Guide Me Retail Kit mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | Accu-Chek Guide Me | ||
28 | 00365702730106 | 08499888001 | ACCU-CHEK GUIDE ME HNP KIT MG/DL US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK GUIDE ME | |
29 | 00365702702219 | 07531567160 | 07531567160 | Accu-Chek Fastclix AST Kit USA | QRL | Multiple Use Blood Lancet For Single Patient Use Only | Accu-Chek Fastclix | |
30 | 00365702702196 | 03450074001 | 03450074001 | Accu-Chek Safe-T-Pro Plus 5ct | FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 | Accu-Chek Safe-T-Pro |
31 | 00365702702141 | 08029016160 | 08029016160 | Accu-Chek Safte-T-Pro Plus 200ct Coag 6/cs | FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 | Accu-Chek Safe-T-Pro |
32 | 00365702702066 | 07400942001 | 07400942001 | ACCU-CHEK GUIDE METER ONLY MG/DL US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK GUIDE |
33 | 00365702702042 | 07400926001 | 07400926001 | ACCU-CHEK GUIDE RETAIL KIT MG/DL | NBW | System, Test, Blood Glucose, Over The Counter | ACCU-CHEK GUIDE | |
34 | 00365702702035 | 07400870001 | 07400870001 | ACCU-CHEK GUIDE SAMPLE KIT MG/DL | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK GUIDE |
35 | 00365702701977 | 07453701001 | 07453701001 | ACCU-CHEK GUIDE 10CT STRIP 36/CS | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK GUIDE | |
36 | 00365702701953 | 07453736001 | 07453736001 | ACCU-CHEK GUIDE 50CT STRIP 36/CS | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK GUIDE | |
37 | 00365702701908 | 08053774001 | 08053774001 | VIAL LBLD 10CT STRIP ACCU-CHEK GUIDE | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK GUIDE |
38 | 00365702700475 | 06372481160 | 06372481160 | Accu-Chek Safe-T-Pro Uno 10ct | FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 | Accu-Chek Safe-T-Pro |
39 | 00365702700468 | 05888662160 | 05888662160 | Accu-Chek Safe-T-Pro Uno 200ct 16/cs | FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 | Accu-Chek Safe-T-Pro |
40 | 00365702688100 | 07748906001 | ACCU-CHEK GUIDE 2-LEVEL CONTROLS US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | ACCU-CHEK GUIDE | ||
41 | 00365702544109 | 06870287001 | ACCU-CHEK AVIVA MG/DL 455 US | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA | |
42 | 00365702481107 | 05864666160 | 05864666160 | Accu-Chek Fastclix MO/RP/AST Kit USA | QRL | Multiple Use Blood Lancet For Single Patient Use Only | Accu-Chek Fastclix | |
43 | 00365702438101 | 06908349001 | 06908349001 | ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS |
44 | 00365702437104 | 06908314001 | 06908314001 | ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK AVIVA PLUS | |
45 | 00365702436107 | 06908373001 | ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS | |
46 | 00365702408104 | 06908268001 | 06908268001 | ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK AVIVA PLUS | |
47 | 00365702407107 | 06908217001 | 06908217001 | ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS |
48 | 00365702405103 | 06908152001 | 06908152001 | ACCU-CHEK AVIVA PLUS 10CT STRIP BRK | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS |
49 | 00365702291102 | 05360188001 | 05360188001 | Accu-Chek Fastclix 102 Lancets DME 12/cs | QRL | Multiple Use Blood Lancet For Single Patient Use Only | Accu-Chek Fastclix | |
50 | 00365702288102 | 05360145001 | 05360145001 | Accu-Chek Fastclix 102 Lancets Rtl 12/cs | QRL | Multiple Use Blood Lancet For Single Patient Use Only | Accu-Chek Fastclix |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00810042683181 | 702012 | 702012 | HCG URINE CONTROL Negative/Low Positive 2x4mL KITBOX | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
2 | 00810042683174 | 18003155 | hCG Low Positive/Negative Urine 2x5mL Kitbox | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
3 | 00810042683129 | 2110005 | 18000347 | CenMed hCG URINE Control POSITIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
4 | 00810042683112 | 2110007 | 18000346 | CenMed hCG URINE Control NEGATIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
5 | 00810042682962 | 2122015 | 18000698 | CenMed hCG Serum Control POSITIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
6 | 00810042682948 | 2122017 | 18000697 | CenMed hCG Serum Control NEGATIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
7 | 00810042682900 | Custom QC31 | PREGNANCY SKREEN Custom hCG Serum 4mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
8 | 00810042682894 | Custom QC30 | PREGNANCY SKREEN Custom hCG Serum 5mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
9 | 00810042681415 | Custom QC25 | PREGNANCY SKREEN Custom hCG Liquid Urine 50mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
10 | 00810042681408 | Custom QC24 | PREGNANCY SKREEN Custom hCG Liquid Urine 20mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
11 | 00810042681392 | Custom QC23 | PREGNANCY SKREEN Custom hCG Liquid Urine 5mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
12 | 00810042681385 | Custom QC22 | PREGNANCY SKREEN Custom hCG Liquid Urine 2mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
13 | 00810042681347 | Custom QC18 | PREGNANCY SKREEN Custom hCG Liquid Urine 4cc kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
14 | 00810042681156 | 18030367 | 18030367 | HCG Urine 2x4mL dropper Kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
15 | 00810042681095 | 18000656 | 18000656 | CONSULT HCG 4mL KIT | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
16 | 00810042681088 | 18000443 | 18000443 | Cardinal HCG 4mL Kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
17 | 00810042681071 | 18000442 | 18000442 | ALERE HCG 4mL KIT | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
18 | 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 | |
19 | 00804084000143 | AGS-1112 | IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips) | IDEAL LIFE INC | ||
20 | 00793150629794 | IGM-1003A | INFCN003L | Glucose Control Solution | Oh’Care Lite Glucose Control Solution | OSANG HEALTHCARE CO., LTD. |
21 | 00793150629763 | IGM-1003A | Blood Glucose Monitoring System Kit | Oh’Care Lite Blood Glucose Monitoring System Kit | OSANG HEALTHCARE CO., LTD. | |
22 | 00763924540105 | MD540 | Lipid and Glucose Measuring System | LipidPlus® Glucose Test Strips | JANT PHARMACAL CORPORATION | |
23 | 00748349000717 | 10001 | 10001 | Glucose Pilot - The Complete Glucose Monitoring System | Glucose Pilot | SYNTRON BIORESEARCH, INC. |
24 | 00742860100178 | 176 | 176 | OSOM H. Pylori Control Kit | SEKISUI DIAGNOSTICS, LLC | |
25 | 00742860100093 | 138 | 138 | HCG SERUM CONTROL KIT | SEKISUI DIAGNOSTICS, LLC | |
26 | 00732671109422 | 942-2 | 942-2 | Control Solution - L2 (High) | Pip | AMITY HOLDINGS, LLC |
27 | 00732671009425 | 942-1 | 942-1 | Control Solution - L1 (low) | Pip | AMITY HOLDINGS, LLC |
28 | 00732671009401 | 940 | 940 | Blood Glucose Test Meter | Pip | AMITY HOLDINGS, LLC |
29 | 00699073704320 | 70432 | 70432 | FreeStyle Control Solution | FreeStyle | ABBOTT DIABETES CARE INC |
30 | 00699073140029 | 14002 | 14002 | FreeStyle Control Solution | FreeStyle | ABBOTT DIABETES CARE INC |
31 | 00695684781026 | 78102 | AimStrip® Hb Optical Verifiers are made out of plastic and work with the AimStri AimStrip® Hb Optical Verifiers are made out of plastic and work with the AimStrip® HB Hemoglobin (Hb) Meter. | AIMSTRIP HEMOGLOBIN OPTICAL VERIFIERS | GERMAINE LABORATORIES, INC | |
32 | 00695684775124 | ILM-0001A | blood glucose meter and test strip control solution-level 1,2,3 | AimStrip Tandem Glucose control solution | OSANG HEALTHCARE CO., LTD. | |
33 | 00695684774127 | ILM-0001A | Lipid measuring meter and Triglycerides test strip control solution level 1,2 | AimStrip Tandem Total Triglycerides Control Solution | OSANG HEALTHCARE CO., LTD. | |
34 | 00695684773120 | ILM-0001A | Lipid measuring meter and Total Cholesterol test strip control solution level 1,2 | AimStrip Tandem Total Cholesterol Control Solution | OSANG HEALTHCARE CO., LTD. | |
35 | 00695684773014 | ILM-0001A | Lipid and Glucose Measuring System | AimStrip Tandem Lipid Profile and glucose measuring system | OSANG HEALTHCARE CO., LTD. | |
36 | 00695684373122 | 37312 | Blood glucose control solution for use with AimStrip® Plus Blood Glucose Test St Blood glucose control solution for use with AimStrip® Plus Blood Glucose Test Strips & meter for testing blood glucose levels | AIMSTRIP PLUS, GLUCOSE CONTROL SOLUTION | GERMAINE LABORATORIES, INC | |
37 | 00695684131128 | 13112 | Ketone controls for use with ketone tests, 1 Positive and 1 Negative | KETONE SERUM CONTROLS | GERMAINE LABORATORIES, INC | |
38 | 00682607571017 | G117-108 | 757101 | Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Voice Blood Glucose Monitoring System | ACON LABORATORIES, INC. |
39 | 00682607558315 | G125-12L | Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2 | On Call Pro Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
40 | 00682607558117 | G115-107 | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Vivid Pal Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
41 | 00682607557325 | G125-12D | Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2 | On Call Express Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
42 | 00682607557158 | G115-10D | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
43 | 00682607556311 | G125-122 | Glucose Control Solution Kit includes 2mL Control 1, 2mL Control 2 | On Call Vivid Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
44 | 00682607556113 | G115-102 | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Vivid Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
45 | 00682607550128 | G115-10S | 755012 | Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Mobile Blood Glucose Monitoring System | ACON LABORATORIES, INC. |
46 | 00682607535316 | G123-311 | Glucose Control Solution Kit includes 2mL Control 1, 2mL Control 2 | On Call Plus Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
47 | 00682607535118 | G113-111 | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Plus Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
48 | 00682607200023 | C122-3041 | 2mL bottles of Level 0, Level 1, Level 2 | Mission Plus Hemoglobin (Hb) Control Solution Kit | ACON LABORATORIES, INC. | |
49 | 00681131280624 | 784001 | The ReliOn Premier Classic Blood Glucose Monitoring System is intended for the q The ReliOn Premier Classic 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. | ReliOn™ Premier Classic Meter | WAL-MART STORES, INC. | |
50 | 00681131169851 | 780001 | The ReliOn Premier Voice Blood Glucose Monitoring System is intended for the qua The ReliOn Premier Voice 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 the forearm, palm, thigh and calf. | ReliOn™ Premier Voice Basic Meter | WAL-MART STORES, INC. |