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 | 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 |
30 | 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 |
31 | 00365702702066 | 07400942001 | 07400942001 | ACCU-CHEK GUIDE METER ONLY MG/DL US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK GUIDE |
32 | 00365702702042 | 07400926001 | 07400926001 | ACCU-CHEK GUIDE RETAIL KIT MG/DL | NBW | System, Test, Blood Glucose, Over The Counter | ACCU-CHEK GUIDE | |
33 | 00365702702035 | 07400870001 | 07400870001 | ACCU-CHEK GUIDE SAMPLE KIT MG/DL | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK GUIDE |
34 | 00365702701977 | 07453701001 | 07453701001 | ACCU-CHEK GUIDE 10CT STRIP 36/CS | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK GUIDE | |
35 | 00365702701953 | 07453736001 | 07453736001 | ACCU-CHEK GUIDE 50CT STRIP 36/CS | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK GUIDE | |
36 | 00365702701908 | 08053774001 | 08053774001 | VIAL LBLD 10CT STRIP ACCU-CHEK GUIDE | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK GUIDE |
37 | 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 |
38 | 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 |
39 | 00365702688100 | 07748906001 | ACCU-CHEK GUIDE 2-LEVEL CONTROLS US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | ACCU-CHEK GUIDE | ||
40 | 00365702544109 | 06870287001 | ACCU-CHEK AVIVA MG/DL 455 US | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA | |
41 | 00365702481107 | 05864666160 | 05864666160 | Accu-Chek Fastclix MO/RP/AST Kit USA | QRL | Multiple Use Blood Lancet For Single Patient Use Only | Accu-Chek Fastclix | |
42 | 00365702438101 | 06908349001 | 06908349001 | ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS |
43 | 00365702437104 | 06908314001 | 06908314001 | ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK AVIVA PLUS | |
44 | 00365702436107 | 06908373001 | ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS | |
45 | 00365702408104 | 06908268001 | 06908268001 | ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK AVIVA PLUS | |
46 | 00365702407107 | 06908217001 | 06908217001 | ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C | LFR | Glucose Dehydrogenase, Glucose | 2 | 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 | 10810011730370 | HH-X-T, IC | Twist Lancets+Lancing Device | Care Touch | TIANJIN HUAHONG TECHNOLOGY CO., LTD. | |
2 | 10810011730349 | HH-X-T, IC | Twist Lancets+Lancing Device | Care Touch | TIANJIN HUAHONG TECHNOLOGY CO., LTD. | |
3 | 10810011730233 | IC | Care Touch | TIANJIN HUAHONG TECHNOLOGY CO., LTD. | ||
4 | 10810011730226 | IK,28G | HUAHONG | TIANJIN HUAHONG TECHNOLOGY CO., LTD. | ||
5 | 07613336173046 | 07313462001 | 07313462001 | CoaguChek XS Softclix Bulk Black 100 PC | Accu-Chek Coaguchek Softclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
6 | 06971292001560 | LD11000B1 | The RightLance Blood Lancing System is intended for the hygienic collection of c The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
7 | 06971292001553 | LD11000P2 | The RightLance Blood Lancing System is intended for the hygienic collection of c The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
8 | 06971292001546 | SLD11000B1 | The RightLance Blood Lancing System is intended for the hygienic collection of c The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
9 | 06971292001539 | LD51000B1 | The RightLance Blood Lancing System is intended for the hygienic collection of c The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
10 | 06971292001522 | LD4300091 | The RightLance Blood Lancing System is intended for the hygienic collection of c The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
11 | 06971292001515 | LD33000G1 | The RightLance Blood Lancing System is intended for the hygienic collection of c The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
12 | 06971292001508 | LD3300001 | The RightLance Blood Lancing System is intended for the hygienic collection of c The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
13 | 06971292001492 | LD33000Y1 | The RightLance Blood Lancing System is intended for the hygienic collection of c The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
14 | 06971292001485 | LD33000B1 | The RightLance Blood Lancing System is intended for the hygienic collection of c The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
15 | 06971292001478 | LD33000P1 | The RightLance Blood Lancing System is intended for the hygienic collection of c The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
16 | 06971292001461 | LD2111012 | The RightLance Blood Lancing System is intended for the hygienic collection of c The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
17 | 06971292001454 | LD1100011 | The RightLance Blood Lancing System is intended for the hygienic collection of c The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
18 | 06945630113864 | 02-2201 | STERILANCE | STERILANCE MEDICAL (SUZHOU) INC. | ||
19 | 04713648766493 | lancet | ApexBio SteriLance BLOOD LANCET (Sterile) | APEX BIOTECHNOLOGY CORP. | ||
20 | 04015630083923 | 09770526001 | 09770526001 | Accu-Chek Fastclix 6 Lancet Drum Bulk 100 | Accu-Chek Fastclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
21 | 04015630065615 | 07523211001 | 07523211001 | Accu-Chek Fastclix Device Bulk 100 | Accu-Chek Fastclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
22 | 00898302001005 | LAND | 98302-0001-00 | Simple Diagnostics Universal Lancing Device | Simple Diagnostics | SIMPLE DIAGNOSTICS INC |
23 | 00894030002048 | SHN02GM0123 | Embrace Lancet 30G | Embrace Lancet | OMNIS HEALTH, LLC | |
24 | 00812608030057 | 02397301 | OTDP Lancing Device US | Box of 1 Lancing Device and 10 Sterile Lancets 30 Gauge | OneTouch Delica Plus Lancing Device | ASAHI POLYSLIDER COMPANY,LIMITED |
25 | 00810011730212 | HH-XIII-T | ReliOn | TIANJIN HUAHONG TECHNOLOGY CO., LTD. | ||
26 | 00365702702660 | 09556672001 | 09556672001 | Relion Platinum Lancing Device | RELION | ROCHE DIAGNOSTICS OPERATIONS, INC. |
27 | 00365702702240 | 08015333001 | 08015333001 | CoaguChek Softclix Lancets USA 10ct | Accu-Chek Coaguchek Softclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
28 | 00365702702219 | 07531567160 | 07531567160 | Accu-Chek Fastclix AST Kit USA | Accu-Chek Fastclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
29 | 00365702702165 | 08120242001 | 08120242001 | CoaguChek XS SC Lancing Device Kit 12/cs | Accu-Chek Coaguchek Softclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
30 | 00365702562103 | 06979009001 | 06979009001 | CoaguChek Softclix Lancets 25ct 100/cs | Accu-Chek Coaguchek Softclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
31 | 00365702481107 | 05864666160 | 05864666160 | Accu-Chek Fastclix MO/RP/AST Kit USA | Accu-Chek Fastclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
32 | 00365702291102 | 05360188001 | 05360188001 | Accu-Chek Fastclix 102 Lancets DME 12/cs | Accu-Chek Fastclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
33 | 00365702288102 | 05360145001 | 05360145001 | Accu-Chek Fastclix 102 Lancets Rtl 12/cs | Accu-Chek Fastclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |