FDA.reportPublic FDA data

RightLance

Primary DI
04712558762694
Brand
RightLance
Company
VISGENEER, INC.
Model
RC-AD-VIU
Device description
reusable lancing device that is to be cleaned and disinfected between each use, to be used with the sterile single-use lancets
Published
2025-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QRLMultiple Use Blood Lancet For Single Patient Use Only

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRLMultiple Use Blood Lancet For Single Patient Use OnlyGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222034000RightLance Blood Lancing SystemBeijing Ruicheng Medical Supplies Co., Ltd.2022-09-07QRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04712558762694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712558762694047125587626944712558762694

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, reusableA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656031619
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04712558769006eBsensoreB-G2026-04-17
04712558769020eBsensorLS-012026-04-17
04712558769082eBcarryoneB-A2026-04-17
04712558769167eBcarryonLS-012026-04-17
04712558762342Visgeneer30G Ihttps://gudid.fda.gov/gudid/app/admin/udi/recordDe2025-02-16
04712558761116eBuricacideB-U012023-07-05
04712558761123eBuricacideBuricacid2023-07-05
04712558769037eB-serieseB-series2023-07-05
04712558761277LANCET30G2023-07-05
04712558769402eBchekeB-S012023-07-05
04712558769419eBchekLS-032023-07-05
14712558769409eBchekeB-S012021-03-25
14712558769416eBchekeB-S012021-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810011730700GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-11
00810011730694GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-09
00850080988428AUVONUAN HEALTHCARE LIMITEDQRL2026-05-09
00810011730687GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-06
00860015383952True IntegralTRUE INTEGRAL INCQRL2026-04-14
16945630142007STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
36945630142001STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
00850080988107AUVONUAN HEALTHCARE LIMITEDQRL2026-03-02
00850080988114AUVONUAN HEALTHCARE LIMITEDQRL2026-03-02
00810079240579Teladoc Health, Inc.Teladoc Health, Inc.QRL2026-02-17
00810079240586Teladoc Health, Inc.Teladoc Health, Inc.QRL2026-02-17
00850080988091AUVONUAN HEALTHCARE LIMITEDQRL2026-02-06
00682607541829On Call Stealth Lancing DeviceAcon Laboratories, Inc.QRL2026-02-03
20682607541823On Call Stealth Lancing DeviceAcon Laboratories, Inc.QRL2026-02-03
00810011730649HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
50810011730644HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
00810011730656HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
00810011730663AllevyTianjin Huahong Technology Co., Ltd.QRL2025-12-24
06949517009462N/MShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-12-10
00850065253305LIVE TULA Lancing DeviceTULA HEALTH, INC.QRL2025-12-03
MHC1808002EasyTouchMHC MEDICAL PRODUCTS, LLCQRL2025-11-10
00810079240456Teladoc Health, Inc.Teladoc Health, Inc.QRL2025-10-10
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
MHC1708001Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
MHC1730101Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
MHC1732101Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
06949517009028One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-09-14
MHC18080020EasyTouchMHC MEDICAL PRODUCTS, LLCQRL2025-08-04
06949517008847One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27