FDA.reportPublic FDA data

Members Mark

Primary DI
MHC17080012
Brand
Members Mark
Company
WAL-MART STORES, INC.
Model
708001
Device description
Members Mark Lancing Device
Published
2023-04-18
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
MHC17080012PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, single-useA sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051957769
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Model table
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06979191882112Nanacare69791918821122026-07-31
06979191882228Nanacare69791918822282026-07-31
06979191882242Nanacarewhite2026-07-31
06979191882273BadBuddy69791918822732026-07-31
06979191882280Nanacare69791918822802026-07-31
06979191883690EQUATEwhite2026-07-31
06979191883706EQUATEblue2026-07-31
06979191883713EQUATEwhite2026-07-31
06979191883720EquateWhite2026-07-31
00194346614035equateBPHJT3-JWM2026-07-28
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00194346672837EquateEquate 2x12oz2026-06-23
00194346672844EquateEquate 12oz2026-06-23
00194346693122EquateWAL4545V4WAL4545V42026-06-02
00194346693139EquateWAL4245V4WAL4245V42026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428167298TRUEdrawTRIVIDIA HEALTH, INC.QRL2026-08-14
00810011730755leraiseTianjin Huahong Technology Co., Ltd.QRL2026-07-10
00810011730779VivaGuardTianjin Huahong Technology Co., Ltd.QRL2026-07-10
00810011730786VivaGuardTianjin Huahong Technology Co., Ltd.QRL2026-07-10
00810011730793HuahongTianjin Huahong Technology Co., Ltd.QRL2026-07-10
00194631000079Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-09
00194631000024Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000031Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000048Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000062Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
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