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 | 00885325001693 | 164503 | CareSens N Feliz Blood Glucose Monitoring System | CareSens N Feliz | I-SENS, INC. | |
2 | 00885325001686 | 164508 | CareSens N Feliz BT Blood Glucose Monitoring System | CareSens N Feliz BT | I-SENS, INC. | |
3 | 00885325001402 | 343262 | Tempo Blood Glucose Monitoring System | Tempo | I-SENS, INC. | |
4 | 00885325001389 | 343264 | Tempo Blood Glucose Monitoring System | Tempo | I-SENS, INC. | |
5 | 00885325001372 | 164372 | CareSens N Plus BT Blood Glucose Monitoring System | CareSens N Plus BT | I-SENS, INC. | |
6 | 00885325001327 | 164307 | CareSens N Blood Glucose Monitoring System | CareSens N | I-SENS, INC. | |
7 | 00885325001310 | 164284 | CareSens N Blood Glucose Monitoring System | CareSens N | I-SENS, INC. | |
8 | 00885325001266 | 164221 | CareSens II Blood Glucose Monitoring System (Basic meter set) | CareSens II | I-SENS, INC. | |
9 | 00885325001211 | 164303-204 | CareSens N Blood Glucose Monitoring System with Test Strips (10T) | CareSens N | I-SENS, INC. | |
10 | 00885325001105 | 164303-203 | CareSens N Blood Glucose Monitoring System (White) | CareSens N | I-SENS, INC. | |
11 | 00885325000849 | 164446-201 | CareSens N Voice Multi Blood Glucose Monitoring System | CareSens N Voice Multi | I-SENS, INC. | |
12 | 00885325000757 | 520001 | COOL Blood Glucose Meter | COOL | I-SENS, INC. | |
13 | 00885325000443 | 164442-202 | CareSens N Voice Blood Glucose Meter | CareSens N Voice | I-SENS, INC. | |
14 | 00885325000436 | 164422 | CareSens N POP Blood Glucose Monitoring System | CareSens N POP | I-SENS, INC. | |
15 | 00885325000375 | 521100 | COOL Blood Glucose Monitoring System | COOL | I-SENS, INC. | |
16 | 00885325000115 | 164301-202 | CareSens N Blood Glucose Meter | CareSens N | I-SENS, INC. | |
17 | 00885325000047 | 155300-201 | CareSens N Blood Glucose Meter | CareSens N (MedPoint Diagnostics) | I-SENS, INC. | |
18 | 00885325000016 | 164303-201 | CareSens N Blood Glucose Monitoring System | CareSens N | I-SENS, INC. | |
19 | 00885017000638 | EM44 | a bottle of level 2 control solution | EM 15 Blood Glucose Level 2 Control Solution | EPS BIO TECHNOLOGY CORP. | |
20 | 00885017000591 | EasyMax | 1 bottle of Level 2 Control Solution | EasyMax Blood Glucose Level 2 Control Solution | EPS BIO TECHNOLOGY CORP. | |
21 | 00885017000584 | EM44 | a bottle of level 1 and a bottle of level 2 control solution | EM 15 Blood Glucose Level 1 and Level 2 Control Solution | EPS BIO TECHNOLOGY CORP. | |
22 | 00885017000560 | EM44 | a bottle of level 2 control solution | EasyMax 15 NHCS Set EN | EPS BIO TECHNOLOGY CORP. | |
23 | 00885017000553 | EasyMax | 1 bottle of Level 2 Solution | EasyMax NHCS Set EN | EPS BIO TECHNOLOGY CORP. | |
24 | 00885017000461 | EM66 | 1 blood glucose meter; 10 strips in a vial; level 2 control solution in a convenience kit | FortisCare Self-Monitoring Blood Glucose System | EPS BIO TECHNOLOGY CORP. | |
25 | 00885017000447 | EM44 | 50 strips in a vial | FortisCare Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
26 | 00885017000416 | EM44 | 50 strips in a vial | EasyMax 15 Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
27 | 00885017000362 | EM44 | a bottle of level 1 control solution | EM 15 Blood Glucose Level 1 Control Solution | EPS BIO TECHNOLOGY CORP. | |
28 | 00885017000355 | EasyMax | 10 strips in a vial | EasyMax Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
29 | 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) | EasyMax NG Self-Monitoring Blood Glucose System | EPS BIO TECHNOLOGY CORP. | |
30 | 00885017000317 | EasyMax T1 Pro | 50 strips in a vial | FortisCare Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
31 | 00885017000300 | EasyMax T1 Pro | 1 blood glucose meter | FortisCare Self-Monitoring Blood Glucose System | EPS BIO TECHNOLOGY CORP. | |
32 | 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. | 25 EasyMax 15 FTS Set EN-ES | EPS BIO TECHNOLOGY CORP. | |
33 | 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. | 25 EasyMax FTS Set EN-ES | EPS BIO TECHNOLOGY CORP. | |
34 | 00885017000263 | EasyMax G1 FTS | 25 strips in a vial. | FortisCare Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
35 | 00885017000171 | EM44 | 10 strips in a vial | EasyMax 15 Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
36 | 00885017000102 | EMMU | Semi kit: one blood glucose meter | EasyMax LTC Self-Monitoring Blood Glucose System | EPS BIO TECHNOLOGY CORP. | |
37 | 00885017000065 | EMMU | Semi kit: one blood glucose meter | EasyMax NG Self-Monitoring Blood Glucose System | EPS BIO TECHNOLOGY CORP. | |
38 | 00885017000058 | EMV | one blood glucose meter | EasyMax V Self-Monitoring Blood Glucose System | EPS BIO TECHNOLOGY CORP. | |
39 | 00885017000010 | EasyMax | 50 strips in a vial | EasyMax Blood Glucose Test Strip | EPS BIO TECHNOLOGY CORP. | |
40 | 00884389176750 | MPH5540 | MPH5540 | METER, GLUCOSE, MINI, SINGLE PATIENT USE | Medline | MEDLINE INDUSTRIES, INC. |
41 | 00884389106313 | MPH5545 | MPH5545 | DBD-STARTER KIT, GLUCOSE, EVENCARE MINI | Medline | MEDLINE INDUSTRIES, INC. |
42 | 00884389102568 | MPH1550 | MPH1550 | STRIP,EVENCARE G2,600 EA/CS,50 EA/BX | Medline | MEDLINE INDUSTRIES, INC. |
43 | 00884389102551 | MPH1540 | MPH1540 | METER, GLUCOSE, EVENCARE G2 | Medline | MEDLINE INDUSTRIES, INC. |
44 | 00884389102544 | MPH1560 | MPH1560 | CONTROL,EVENCARE G2 HI LO | Medline | MEDLINE INDUSTRIES, INC. |
45 | 00884389102407 | MPH1545 | MPH1545 | STARTER KIT, GLUCOSE, EVENCARE G2 1EA | Medline | MEDLINE INDUSTRIES, INC. |
46 | 00883489310309 | GE100 | GE | BIONIME CORPORATION | ||
47 | 00883489310293 | GM250 | Rightest | BIONIME CORPORATION | ||
48 | 00883489002419 | Diathrive+ Blood Glucose Test Strip | 99GS280D51 | 25 strips - 80883489002415 | ODM | BIONIME CORPORATION |
49 | 00883489002396 | Diathrive+ Bluetooth Blood Glucose Monitoring System | 99GM282DR1 | 1 meter - 00883489002396 | ODM | BIONIME CORPORATION |
50 | 00883489002372 | Diathrive+ Blood Glucose Monitoring System | 99GM280DR1 | 1 meter - 00883489002372 | ODM | BIONIME CORPORATION |