No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00894030002697 | APX02AB0511 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Control Solution Hi | ||
2 | 00894030002666 | APX01AB0500VK | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Value Kit (50ct Included) | ||
3 | 00894030002543 | APX01AGS0100-SR | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials) | ||
4 | 00894030002536 | APX01AK0200VK | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Meter Value Pack (incl. 50ct) | ||
5 | 00894030002376 | APX02AB0811 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace EVO Control Solution, L2 (Medium) | ||
6 | 00894030002482 | APX01GS0100-L | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | EmbraceEVO Gestational Diabetes Package - LARGE (9 vials) | ||
7 | 00894030002017 | APX01AB200 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Meter, Meter Only | ||
8 | 00894030002581 | APX02GS0202RF | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Gestational Diabetes Package - RETAIL (5 vials) | ||
9 | 00894030002413 | ALL02AB0210 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace Pro Control Solution (L1/Normal; L2/High) | ||
10 | 00894030002703 | APX02AB0510 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Control Solution Low | ||
11 | 00894030002574 | APX02GS0202RF | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Gestational Diabetes - Strips Refill Bundle (4 vials) | ||
12 | 00894030002475 | APX01GS0100-S | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | EmbraceEVO Gestational Diabetes Package - SMALL (5 vials) | ||
13 | 00894030002420 | APX01AB0851 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace EVO Mini Meter, all-in-one kit, RETAIL | ||
14 | 00894030002345 | APX02AB0810 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace EVO Control Solution, L1 (Low) | ||
15 | 00894030002079 | APX02AB310 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace Control Solution, L1 (Low) | ||
16 | 00894030002086 | APX02AB0200 | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace Strips, 10-ct | ||
17 | 00894030002062 | APX02AB0311 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace Control Solution, L2 (High) | ||
18 | 00894030002352 | APX02AB0802 | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace EVO Strips, 50ct Vial - RETAIL | ||
19 | 00894030002338 | APX02AB0202MO | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace Strips, 50ct Vial - Mail Order (Yellow Band) | ||
20 | 00894030002680 | APX02AB0502 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace 50ct Test Strip | ||
21 | 00894030002406 | ALL02AB0202 | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace Pro Strips, 50-ct vials | ||
22 | 00894030002390 | ALL01AB0200 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Pro Meter | ||
23 | 00894030002260 | APX01AB0300 | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Meter Kit (w/10 ct) | ||
24 | 00894030002567 | APX01GS0200-L | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Gestational Diabetes Package - LARGE (9 vials) | ||
25 | 00894030002550 | APX01GS0200-S | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | Embrace Gestational Diabetes Package - SMALL (5 vials) |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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. |
2 | 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. |
3 | 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. |
4 | 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. |
5 | 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. |
6 | 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. |
7 | 00389154000570 | AC-11 vial | 3S-01-16003C | GL GoodLife AC300 Blood Glucose Test Strip | GL GoodLife AC300 Test Strip-Vial | HMD BIOMEDICAL INC. |
8 | 00389154000549 | 3C-01-160032 | 3C-01-160032 | GL GoodLife Glucose Control Solution | GL GoodLife Glucose Control Solutions | HMD BIOMEDICAL INC. |
9 | 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. |
10 | 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. |
11 | 00389154000389 | AC11 | 3K-01-16003H | Rosie SmartMeter Blood Glucose Monitoring System | Rosie SmartMeter | HMD BIOMEDICAL INC. |
12 | 00389154000372 | IG01 | 3K-01-810037 | GL GoodLife Blood Glucose Monitoring System(Cloudia) | GL GoodLife | HMD BIOMEDICAL INC. |
13 | 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. |
14 | 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. |
15 | 00389154000198 | AC11 | 3K-01-16003C | GL GoodLife AC-300 Blood Glucose Monitoring System | GL GoodLife | HMD BIOMEDICAL INC. |
16 | 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. |
17 | 00385930011112 | TD-4277 | Ultra TRAK TM ULTIMATE TEST STRIP (50 Test Strips) | VERTEX DIAGNOSTICS LLC | ||
18 | 00365702726109 | 08053723001 | Accu-Chek Guide Mail Order 50 ct | Accu-Chek Guide | ROCHE DIAGNOSTICS OPERATIONS, INC. | |
19 | 00365702719101 | 08256292001 | Accu-Chek Guide 50ct HN 36/cs | Accu-Chek Guide | ROCHE DIAGNOSTICS OPERATIONS, INC. | |
20 | 00365702712102 | 07453744001 | 07453744001 | ACCU-CHEK GUIDE 100CT STRIP 24/CS | ACCU-CHEK GUIDE | ROCHE DIAGNOSTICS OPERATIONS, INC. |
21 | 00365702710108 | 07453710001 | Accu-Chek Guide 25ct Strip 36/cs | Accu-Chek Guide | ROCHE DIAGNOSTICS OPERATIONS, INC. | |
22 | 00365702702394 | 08340331001 | ACCU-CHEK AVIVA MG/DL 455 US NON-VA | Accu-Chek Aviva | ROCHE DIAGNOSTICS OPERATIONS, INC. | |
23 | 00365702701977 | 07453701001 | 07453701001 | ACCU-CHEK GUIDE 10CT STRIP 36/CS | ACCU-CHEK GUIDE | ROCHE DIAGNOSTICS OPERATIONS, INC. |
24 | 00365702701953 | 07453736001 | 07453736001 | ACCU-CHEK GUIDE 50CT STRIP 36/CS | ACCU-CHEK GUIDE | ROCHE DIAGNOSTICS OPERATIONS, INC. |
25 | 00365702701908 | 08053774001 | 08053774001 | VIAL LBLD 10CT STRIP ACCU-CHEK GUIDE | ACCU-CHEK GUIDE | ROCHE DIAGNOSTICS OPERATIONS, INC. |
26 | 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. | Accu-Chek Compact Plus | ROCHE DIAGNOSTICS OPERATIONS, INC. | |
27 | 00365702700949 | 06333796002 | LABELED VIAL A/C NANO 10CT STRIP | ACCU-CHEK NANO | ROCHE DIAGNOSTICS OPERATIONS, INC. | |
28 | 00365702700932 | 06908420002 | VIAL LBLD 10CT STRIP AC AVIVA PLUS BRK | ACCU-CHEK AVIVA PLUS | ROCHE DIAGNOSTICS OPERATIONS, INC. | |
29 | 00365702602106 | 07299702001 | 07299702001 | ACCU-CHEK PERFORMA US 50 CT 36/CS F2 | ACCU-CHEK PERFORMA | ROCHE DIAGNOSTICS OPERATIONS, INC. |
30 | 00365702595101 | 07189494001 | 07189494001 | ACCU-CHEK AVIVA EXPERT DEMO KIT | ACCU-CHEK AVIVA EXPERT | ROCHE DIAGNOSTICS OPERATIONS, INC. |
31 | 00365702594104 | 07189486001 | 07189486001 | ACCU-CHEK AVIVA EXPERT DEMO CUSTOMER PK | ACCU-CHEK AVIVA EXPERT | ROCHE DIAGNOSTICS OPERATIONS, INC. |
32 | 00365702580107 | 07162758001 | 07162758001 | ACCU-CHEK AVIVA EXPERT CUSTOMER PACK | ACCU-CHEK AVIVA EXPERT | ROCHE DIAGNOSTICS OPERATIONS, INC. |
33 | 00365702544109 | 06870287001 | ACCU-CHEK AVIVA MG/DL 455 US | ACCU-CHEK AVIVA | ROCHE DIAGNOSTICS OPERATIONS, INC. | |
34 | 00365702514102 | 06648266001 | 06648266001 | ACCU-CHEK SMART VIEW CONTROL 2 | ACCU-CHEK SMART VIEW | ROCHE DIAGNOSTICS OPERATIONS, INC. |
35 | 00365702495104 | 06337562001 | ACCU-CHEK SMART VIEW MAIL ORDER STRIP 36 | ACCU-CHEK SMART VIEW | ROCHE DIAGNOSTICS OPERATIONS, INC. | |
36 | 00365702494107 | 06337554001 | 06337554001 | ACCU-CHEK SMART VIEW MED BEN STRIP 36/CS | ACCU-CHEK SMART VIEW | ROCHE DIAGNOSTICS OPERATIONS, INC. |
37 | 00365702493100 | 06337546001 | 06337546001 | ACCU-CHEK SMART VIEW 100CT STRIP 24/CS | ACCU-CHEK SMART VIEW | ROCHE DIAGNOSTICS OPERATIONS, INC. |
38 | 00365702492103 | 06337538001 | 06337538001 | ACCU-CHEK SMART VIEW 50CT STRIP 36/CS | ACCU-CHEK SMART VIEW | ROCHE DIAGNOSTICS OPERATIONS, INC. |
39 | 00365702487109 | 06334059001 | 06334059001 | ACCU-CHEK SMART VIEW 10CT STRIP | ACCU-CHEK SMART VIEW | ROCHE DIAGNOSTICS OPERATIONS, INC. |
40 | 00365702468108 | 05888948160 | 05888948160 | Accu-Chek Compact Plus Clear Control USA | Accu-Chek Compact Plus | ROCHE DIABETES CARE GMBH |
41 | 00365702438101 | 06908349001 | 06908349001 | ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS | ACCU-CHEK AVIVA PLUS | ROCHE DIAGNOSTICS OPERATIONS, INC. |
42 | 00365702437104 | 06908314001 | 06908314001 | ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C | ACCU-CHEK AVIVA PLUS | ROCHE DIAGNOSTICS OPERATIONS, INC. |
43 | 00365702436107 | 06908373001 | ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS | ACCU-CHEK AVIVA PLUS | ROCHE DIAGNOSTICS OPERATIONS, INC. | |
44 | 00365702428102 | 05942861001 | 05942861001 | ACCU-CHEK INFORM II US 50CT 36/CS F2 | ACCU-CHEK INFORM II | ROCHE DIAGNOSTICS OPERATIONS, INC. |
45 | 00365702408104 | 06908268001 | 06908268001 | ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C | ACCU-CHEK AVIVA PLUS | ROCHE DIAGNOSTICS OPERATIONS, INC. |
46 | 00365702407107 | 06908217001 | 06908217001 | ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C | ACCU-CHEK AVIVA PLUS | ROCHE DIAGNOSTICS OPERATIONS, INC. |
47 | 00365702405103 | 06908152001 | 06908152001 | ACCU-CHEK AVIVA PLUS 10CT STRIP BRK | ACCU-CHEK AVIVA PLUS | ROCHE DIAGNOSTICS OPERATIONS, INC. |
48 | 00357599808006 | 72008-01 | 72008-01 | FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System | FreeStyle Precision Pro | ABBOTT DIABETES CARE INC |
49 | 00357599807009 | 72011-01 | 72011-01 | FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System | FreeStyle Precision Pro | ABBOTT DIABETES CARE INC |
50 | 00357599000301 | 71741 | 71741 | FreeStyle Precision Neo Blood Glucose Monitoring System Not For Retail Sale | FreeStyle Precision Neo | ABBOTT DIABETES CARE INC |