FDA.reportPublic FDA data

Manual blood lancing device, reusable

Definition
A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.
GUDID devices
237
Last updated
2026-08-28 10:21:04

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00015482570156LANZO Lancing DeviceArkray USA, Inc.5700152018-10-30
00015482660161ARKRAY Multi-let 2 Lancing DeviceArkray USA, Inc.6600162018-09-24
00050428167298TRUEdrawTRIVIDIA HEALTH, INC.CVS TRUEdraw Lancing Device2026-08-14
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC051880-S2026-08-13
06949517010024medisanaShandong Lianfa Medical Plastic Products CO.,LTDLDF2026-07-14
00810011730786VivaGuardTianjin Huahong Technology Co., Ltd.HH-XIII-T2026-07-10
00840986034992Premier Value AutoletPHARMACY VALUE ALLIANCE, LLCAT 0270CDC2023-02-03
00010939709448TRUEdrawTRIVIDIA HEALTH, INC.Sunmark TRUEdraw Lancing Device2020-12-14
00010939958686TRUEdrawTRIVIDIA HEALTH, INC.TRUEdraw Lancing Device2023-08-01
00011822741088TRUEdrawTRIVIDIA HEALTH, INC.Rite Aid TRUEdraw Lancing Device2020-12-14
00021292142018TRUEdrawTRIVIDIA HEALTH, INC.TRUEdraw Lancing Device2020-12-14
00041220916474H.E.B. inControlH. E. BUTT GROCERY COMPANYAT 0270HEB2023-01-11
00041260007804KrogerKROGER CO., THEAT 0270KRO2021-06-11
00041415031784Publix AutoletPUBLIX SUPER MARKETS, INC.AT 0274PX2023-06-23
00041520870490Care OneAhold U.S.A., Inc.AT 0270AH2023-01-26
00050428645949TRUEdrawTRIVIDIA HEALTH, INC.CVS TRUEdraw Lancing Device2021-12-31
00052569138427TRUEdrawTRIVIDIA HEALTH, INC.HealthMart TRUEdraw Lancing Device2020-12-14
00064562213216Accu-Chek SoftclixRoche Diabetes Care GmbH031466931192023-02-03
00064562213223Accu-Chek SoftclixRoche Diabetes Care GmbH031467071192023-02-03
00064562213261Accu-Chek Safe-T-ProRoche Diabetes Care GmbH037408380012023-02-03
00068113106040ReliOnWAL-MART STORES, INC.08080012022-12-23
00075537257890Accu-Chek Safe-T-ProRoche Diabetes Care GmbH034486220012022-10-19
00087701526206TRUEdrawTRIVIDIA HEALTH, INC.Good Neighbor Lancing Device2020-12-14
00194631000055Tempoi-SENS, Inc.3430042023-01-26
00197344009353MedlineMEDLINE INDUSTRIES, INC.MPHLANCINGPN22024-02-20
00301936702014MICROLET®NEXTASCENSIA DIABETES CARE US INC.67022019-06-06
00301936705015MICROLET®NEXTASCENSIA DIABETES CARE US INC.67052019-06-06
00301936721015MICROLET®NEXTASCENSIA DIABETES CARE US INC.67212019-06-06
00357599000660FreeStyleABBOTT DIABETES CARE INC715822018-02-28
00365702562103Accu-Chek Coaguchek SoftclixRoche Diabetes Care GmbH069790090012022-10-19
00365702700468Accu-Chek Safe-T-ProRoche Diabetes Care GmbH058886621602022-10-19
00365702702141Accu-Chek Safe-T-ProRoche Diabetes Care GmbH080290161602022-10-19
00365702702165Accu-Chek Coaguchek SoftclixRoche Diabetes Care GmbH081202420012022-10-19
00365702702806Accu-Chek FastclixRoche Diagnostics Operations, Inc.099177560012023-03-22
00365702702820Accu-Chek SoftclixRoche Diagnostics Operations, Inc.099177640012023-03-22
00384700270018AutoletOWEN MUMFORD USA INCORPORATEDAT 02702023-02-07
00384700271015AutoletOWEN MUMFORD USA INCORPORATEDAT 02712023-03-01
00384840518902Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC0518902016-09-22
00384840519008Prodigy Voice Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC0519002016-09-22
00384840719507Prodigy Voice Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC0719502016-09-22
00384840761506Prodigy iConnect Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC0761502016-09-23
00635515959347Quality Choice AutoletCHAIN DRUG MARKETING ASSOCIATION, INC.AT 0274QC2023-02-03
00682607541065On Call Lancing DeviceAcon Laboratories, Inc.G124-11A2026-03-18
00682607541829On Call Stealth Lancing DeviceAcon Laboratories, Inc.G124-18A2026-02-03
00732671002334PIPAMITY HOLDINGS, LLC202TK2024-02-29
00732671009357PIPAMITY HOLDINGS, LLC9352019-12-30
00810011730335Care TouchTianjin Huahong Technology Co., Ltd.HH-X-T2025-04-23
00810011730700GoodLifeTianjin Huahong Technology Co., Ltd.HH-XIII-T2026-05-11
00810079240456Teladoc Health, Inc.Teladoc Health, Inc.BG3002025-10-10
00810115891642Diska NulifeDiska LLCHH-XIII-T2023-08-25
00812608030057OneTouch Delica Plus Lancing DeviceASAHI POLYSLIDER COMPANY,LIMITED023973012019-02-28
00840216123465LitetouchAsp Global, LLC20PS-BL2023-11-16
00852982006040ADVOCATE Lancing Device Phoenix BDIABETIC SUPPLY OF SUNCOAST, INC.1502020-06-24
00859509006057One DropINFORMED DATA SYSTEMS INC.8300-105322023-01-06
00883489001290RIGHTESTBIONIME CORPORATIONGD5002023-07-03
00883489001313GEBIONIME CORPORATIONGD5002023-07-03
00885325001716CareSofti-SENS, Inc.1640062023-01-26
03760165449256BEWELL CONNECT MyGluco Lancing deviceVISIOMED GROUPBW-APGL12017-04-28
05907996098774 droplet Genteel lancing deviceHTL STREFA S An/a2021-04-20
06945630112898Sterilance LDE3Sterilance Medical (Suzhou) Inc.02-19032022-07-13
06945630113864STERILANCESterilance Medical (Suzhou) Inc.02-22012022-09-12
06945630120428SMARTMETERSterilance Medical (Suzhou) Inc.LDE42023-07-31
06945630125751EXALANCE LDE4 Lancing DeviceSterilance Medical (Suzhou) Inc.02-22012024-04-24
06945630135309STERiLANCE OneStep Lancing DeviceSterilance Medical (Suzhou) Inc.02-24012025-02-18
06945630136177TRANSTEKSterilance Medical (Suzhou) Inc."""LDE4 02-2201"""2025-04-22
06945630136665sutter syncSterilance Medical (Suzhou) Inc.LDE42025-05-23
06949517090033One +StepShandong Lianfa Medical Plastic Products CO.,LTDLDE2026-04-22
06949517090040One +StepShandong Lianfa Medical Plastic Products CO.,LTDLDE2026-04-22
08800031600017HandyRayLameditech Co., Ltd.LMT-30002018-10-08
10612479265445McKessonMCKESSON MEDICAL-SURGICAL INC.06-005X2023-03-03
10810011730332Care TouchTianjin Huahong Technology Co., Ltd.HH-X-T2023-04-28
16945630112703SteriLance Lancing Device Model LDE 4-ASTSterilance Medical (Suzhou) Inc.02-22012022-06-14
16945630113236SteriLance Lancing Device LDE 4Sterilance Medical (Suzhou) Inc.02-22012022-08-17
16945630123488SteriLance OneStepSterilance Medical (Suzhou) Inc.02-24012024-01-15
16945630132527STERiLANCE LDE4 Lancing DeviceSterilance Medical (Suzhou) Inc.02-22012024-10-23
16945630136167TRANSTEKSterilance Medical (Suzhou) Inc."""LDE4 02-2201"""2025-04-22
16945630142007STERiLANCESterilance Medical (Suzhou) Inc.LDE42026-03-09
20612479126347MckessonMCKESSON MEDICAL-SURGICAL INC.06-0052020-08-04
20612479265725McKessonMCKESSON MEDICAL-SURGICAL INC.50005-0400-052024-01-30
MHC1732101Members MarkMHC MEDICAL PRODUCTS, LLC7321012025-09-16