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 | 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 | |
16 | 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 | |
17 | 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 | |
18 | 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 | |
19 | 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 |
20 | 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 |
21 | 00365702700932 | 06908420002 | VIAL LBLD 10CT STRIP AC AVIVA PLUS BRK | LFR | Glucose Dehydrogenase, Glucose | 2 | ACCU-CHEK AVIVA PLUS | |
22 | 00365702712102 | 07453744001 | 07453744001 | ACCU-CHEK GUIDE 100CT STRIP 24/CS | LFR | Glucose Dehydrogenase, Glucose | ACCU-CHEK GUIDE | |
23 | 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 | |
24 | 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 | |
25 | 00365702732100 | 08499900001 | Accu-Chek Guide Me Meter Only mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Accu-Chek Guide Me | |
26 | 00365702731103 | 08499896001 | Accu-Chek Guide Me Retail Kit mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | Accu-Chek Guide Me | ||
27 | 00365702730106 | 08499888001 | ACCU-CHEK GUIDE ME HNP KIT MG/DL US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ACCU-CHEK GUIDE ME | |
28 | 00365702702219 | 07531567160 | 07531567160 | Accu-Chek Fastclix AST Kit USA | QRL | Multiple Use Blood Lancet For Single Patient Use Only | Accu-Chek Fastclix | |
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 | 00850002860603 | ULT31 | 50002-0860-60 | Simple Diagnostics Blood Lancets | Pharmacist Choice | SIMPLE DIAGNOSTICS INC |
2 | 00812608030217 | 02419901 | OTDP Lancet 30g 30 US | Box of 30 Sterile Lancets 30 Gauge | OneTouch Delica Plus Lancet | ASAHI POLYSLIDER COMPANY,LIMITED |
3 | 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 |
4 | 00812608030040 | 013-027 | OTDP Lancet Bag 30g US/CA | Bag of 10 sterile lancets 30 Gauge | OneTouch Delica Plus Lancet | ASAHI POLYSLIDER COMPANY,LIMITED |
5 | 00812608030033 | 013-026 | OTDP Lancet Bag 33g US/CA | Bag of 10 sterile lancets 33 Gauge | OneTouch Delica Plus Lancet | ASAHI POLYSLIDER COMPANY,LIMITED |
6 | 00812608030026 | 02401101 | OTDP Lancet 30g 100 US | Box of 100 Sterile Lancets 30 Gauge | OneTouch Delica Plus Lancet | ASAHI POLYSLIDER COMPANY,LIMITED |
7 | 00812608030019 | 02400801 | OTDP Lancet 33g 100 US | Box of 100 Sterile Lancets 33 Gauge | OneTouch Delica Plus Lancet | ASAHI POLYSLIDER COMPANY,LIMITED |
8 | 00365702897106 | 03789721001 | 03789721001 | Accu-Chek Softclix Mailorder 100ct 12/cs | Accu-Chek Softclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
9 | 00365702702684 | 09397116001 | 09397116001 | IWL Lancets 10ct | Instant White Label | ROCHE DIAGNOSTICS OPERATIONS, INC. |
10 | 00365702700123 | 09275371001 | 09275371001 | Accu-Chek Softclix AST Kit USA | Accu-Chek Softclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
11 | 00365702400108 | 05509661001 | 05509661001 | Accu-Chek Softclix (black) USA 12/case | Accu-Chek Softclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
12 | 00365702156104 | 04980263001 | 04980263001 | Accu-Chek Softclix HN Lancets 100ct 12cs | Accu-Chek Softclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
13 | 00075537009710 | 11893238160 | 11893238160 | Accu-Chek Softclix Lancets 100ct 12/cs | Accu-Chek Softclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
14 | 10810011730370 | HH-X-T, IC | Twist Lancets+Lancing Device | Care Touch | TIANJIN HUAHONG TECHNOLOGY CO., LTD. | |
15 | 10810011730349 | HH-X-T, IC | Twist Lancets+Lancing Device | Care Touch | TIANJIN HUAHONG TECHNOLOGY CO., LTD. | |
16 | 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. | |
17 | 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. | |
18 | 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. | |
19 | 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. | |
20 | 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. | |
21 | 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. | |
22 | 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. | |
23 | 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. | |
24 | 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. | |
25 | 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. | |
26 | 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. | |
27 | 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. | |
28 | 04713648766493 | lancet | ApexBio SteriLance BLOOD LANCET (Sterile) | APEX BIOTECHNOLOGY CORP. | ||
29 | 04015630084937 | 03144844001 | 03144844001 | Accu-Chek Softclix Lancets 10/pk | Accu-Chek Softclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
30 | 04015630082209 | 05181186001 | 05181186001 | Accu-Chek Softclix Black Bulk 100 | Accu-Chek Softclix | ROCHE DIAGNOSTICS OPERATIONS, INC. |
31 | 00898302140711 | LAN33 | 98302-0140-71 | Simple Diagnostics Lancets | Pharmacist Choice | SIMPLE DIAGNOSTICS INC |
32 | 00898302001609 | LAN31 | 98302-0001-60 | Simple Diagnostics Lancets | Pharmacist Choice | SIMPLE DIAGNOSTICS INC |
33 | 00898302001043 | LAN30 | 98302-0001-04 | Simple Diagnostics Lancets | Pharmacist Choice | SIMPLE DIAGNOSTICS INC |
34 | 00894030002048 | SHN02GM0123 | Embrace Lancet 30G | Embrace Lancet | OMNIS HEALTH, LLC |