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 | 00365702405103 | 06908152001 | 06908152001 | ACCU-CHEK AVIVA PLUS 10CT STRIP BRK | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS |
48 | 00365702291102 | 05360188001 | 05360188001 | Accu-Chek Fastclix 102 Lancets DME 12/cs | QRL | Multiple Use Blood Lancet For Single Patient Use Only | Accu-Chek Fastclix | |
49 | 00365702288102 | 05360145001 | 05360145001 | Accu-Chek Fastclix 102 Lancets Rtl 12/cs | QRL | Multiple Use Blood Lancet For Single Patient Use Only | Accu-Chek Fastclix | |
50 | 00365702220102 | 05177294001 | ACCU-CHEK COMPACT PLUS DME KIT | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK COMPACT PLUS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00793150629787 | IGM-1003A | INFS003L | Blood Glucose Test strips | Oh’Care Lite Blood Glucose Test strips | OSANG HEALTHCARE CO., LTD. |
2 | 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. |
3 | 00793150629763 | IGM-1003A | Blood Glucose Monitoring System Kit | Oh’Care Lite Blood Glucose Monitoring System Kit | OSANG HEALTHCARE CO., LTD. | |
4 | 00725439988933 | TRUE METRIX self monitoring blood glucose meter | RE4097-01 | HEALTHY ACCENTS TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER | TRUE METRIX | TRIVIDIA HEALTH, INC. |
5 | 00713757464802 | TD-4123 | GHT Test Strip | GENESIS HEALTH TECHNOLOGIES, LLC | ||
6 | 00713733069816 | TRUE METRIX Self Monitoring Blood Glucose Meter | RE4019-01 | meijer TRUE METRIX Self Monitoring Blood Glucose Meter | TRUE METRIX | TRIVIDIA HEALTH, INC. |
7 | 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. |
8 | 00699073715012 | 71501 | 71501 | FreeStyle Lite Blood Glucose Monitoring System | FreeStyle Lite | ABBOTT DIABETES CARE INC |
9 | 00699073714992 | 71499 | 71499 | FreeStyle Freedom Lite Blood Glucose Monitoring System | FreeStyle Freedom Lite | ABBOTT DIABETES CARE INC |
10 | 00699073712318 | 71231 | 71231 | FreeStyle InsuLinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |
11 | 00699073712301 | 71230 | 71230 | FreeStyle InsuLinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |
12 | 00699073712295 | 71229 | 71229 | FreeStyle InsuLinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |
13 | 00699073712288 | 71228 | 71228 | FreeStyle Insulinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |
14 | 00699073712271 | 71227 | 71227 | FreeStyle InsuLinx Blood Glucose Test Strips | FreeStyle InsuLinx | ABBOTT DIABETES CARE INC |
15 | 00699073710260 | 71026 | 71026 | FreeStyle Lite Blood Glucose Test Strips | FreeStyle Lite | ABBOTT DIABETES CARE INC |
16 | 00699073709202 | 70920 | 70920 | FreeStyle Freedom Lite Blood Glucose and Monitoring System | FreeStyle Freedom Lite | ABBOTT DIABETES CARE INC |
17 | 00699073709141 | 70914 | 70914 | FreeStyle Freedom Lite Blood Glucose and Monitoring System | FreeStyle Freedom Lite | ABBOTT DIABETES CARE INC |
18 | 00699073708274 | 70827 | 70827 | FreeStyle Lite Blood Glucose Test Strips | FreeStyle Lite | ABBOTT DIABETES CARE INC |
19 | 00699073708229 | 70822 | 70822 | FreeStyle Lite Blood Glucose Test Strips | FreeStyle Lite | ABBOTT DIABETES CARE INC |
20 | 00699073708199 | 70819 | 70819 | FreeStyle Lite Blood Glucose Test Strips | FreeStyle Lite | ABBOTT DIABETES CARE INC |
21 | 00699073708175 | 70817 | 70817 | FreeStyle Lite Blood Glucose Test Strips | FreeStyle Lite | ABBOTT DIABETES CARE INC |
22 | 00699073708052 | 70805 | 70805 | FreeStyle Lite Blood Glucose Monitoring System | FreeStyle Lite | ABBOTT DIABETES CARE INC |
23 | 00699073708045 | 70804 | 70804 | FreeStyle Lite Blood Glucose Monitoring System | FreeStyle Lite | ABBOTT DIABETES CARE INC |
24 | 00699073707925 | 70792 | 70792 | FreeStyle Blood Glucose Test Strips | FreeStyle | ABBOTT DIABETES CARE INC |
25 | 00699073124500 | 12450 | 12450 | FreeStyle Blood Glucose Test Strips | FreeStyle | ABBOTT DIABETES CARE INC |
26 | 00699073124012 | 12401 | 12401 | FreeStyle Blood Glucose Test Strips | FreeStyle | ABBOTT DIABETES CARE INC |
27 | 00699073121011 | 12101 | 12101 | FreeStyle Blood Glucose Test Strips | FreeStyle | ABBOTT DIABETES CARE INC |
28 | 00699073120502 | 12050 | 12050 | FreeStyle Blood Glucose Test Strips | FreeStyle | ABBOTT DIABETES CARE INC |
29 | 00699073110046 | 11004 | 11004 | FreeStyle Freedom Blood Glucose Monitoring System | FreeStyle Freedom | ABBOTT DIABETES CARE INC |
30 | 00699073000026 | 70920 | 70920 | FreeStyle Freedom Lite Blood Glucose and Monitoring System | FreeStyle Freedom Lite | ABBOTT DIABETES CARE INC |
31 | 00699073000019 | 70804 | 70804 | FreeStyle Lite Blood Glucose Monitoring System | FreeStyle Lite | ABBOTT DIABETES CARE INC |
32 | 00681131403214 | TRUE METRIX AIR Self Monitoring Blood Glucose Meter | REA4094-01RX | Relion (Walmart) TRUE METRIX AIR Self Monitoring Blood Glucose Meter | TRUE METRIX AIR | TRIVIDIA HEALTH, INC. |
33 | 00681131240154 | TRUE METRIX AIR Self Monitoring Blood Glucose Meter | REA4094-01 | Relion (Walmart) TRUE METRIX AIR Self Monitoring Blood Glucose Meter | TRUE METRIX AIR | TRIVIDIA HEALTH, INC. |
34 | 00681131060318 | 70122 | 70122 | ReliOn Ultima Blood Glucose Test Strips | ReliOn Ultima | WAL-MART STORES, INC. |
35 | 00681131060301 | 70121 | 70121 | Relion Ultima Blood Glucose Test Strips | ReliOn Ultima | WAL-MART STORES, INC. |
36 | 00681131060295 | 70973 | 70973 | ReliOn Ultima Blood Glucose Test Strips | ReliOn Ultima | WAL-MART STORES, INC. |
37 | 00681131060288 | 70055 | 70055 | Relion Utlima Blood Glucose Monitoring System | ReliOn Ultima | WAL-MART STORES, INC. |
38 | 00657498002216 | 7010-100 | 7010-100 | The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. | STAT-Site WB Blood Glucose Test Strips | STANBIO LABORATORY, L.P. |
39 | 00657498002209 | 7010-050 | 7010-050 | The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. | STAT-Site WB Blood Glucose Test Strips | STANBIO LABORATORY, L.P. |
40 | 00657498002193 | 7010-025 | 7010-025 | The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. | STAT-Site WB Blood Glucose Test Strips | STANBIO LABORATORY, L.P. |
41 | 00607415261097 | Professional Monitoring Blood Glucose Meter TRUE METRIX PRO | RE4068P-01 | MooreBrand Professional Monitoring Blood Glucose Meter TRUE METRIX PRO | TRUE METRIX PRO | TRIVIDIA HEALTH, INC. |
42 | 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. |
43 | 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. |
44 | 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. |
45 | 00389154000617 | AC-11 AC302 | 3K-01-16003N | Only GL GoodLife Blood Glucose Meter. No GCS in package, Economy type | GL GoodLife Blood Glucose Monitoring System | HMD BIOMEDICAL INC. |
46 | 00389154000594 | AC-11 AC302 (vial) | 3S-01-16003E | GL GoodLife Blood Glucose Test Strip(AC-302) | GL GoodLife Blood Glucose Test Strip | HMD BIOMEDICAL INC. |
47 | 00389154000570 | AC-11 vial | 3S-01-16003C | GL GoodLife AC300 Blood Glucose Test Strip | GL GoodLife AC300 Test Strip-Vial | HMD BIOMEDICAL INC. |
48 | 00389154000549 | 3C-01-160032 | 3C-01-160032 | GL GoodLife Glucose Control Solution | GL GoodLife Glucose Control Solutions | HMD BIOMEDICAL INC. |
49 | 00389154000501 | AC11-NFC | delete | Rosie SmartMeter NFC Professional Blood Glucose Monitoring System (Rosie SmartMe Rosie SmartMeter NFC Professional Blood Glucose Monitoring System (Rosie SmartMeter NFC Professional) | Rosie SmartMeter | HMD BIOMEDICAL INC. |
50 | 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. |