FDA.reportPublic FDA data

One +Step

Primary DI
06949517008847
Brand
One +Step
Company
Shandong Lianfa Medical Plastic Products CO.,LTD
Model
LF-TL-23-I
Published
2025-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

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
K222472000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222472000Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd.2022-11-30QRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06949517008847PrimaryGS10
56949517070894Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06949517008847069495170088476949517008847
5694951707089456949517070894

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancet, single-useA sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

Regulatory Flags#

DUNS number
421330121
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06949517090033One +StepLDE2026-04-22
06949517090040One +StepLDE2026-04-22
06949517006201N/MLDC2026-01-31
06949517009462N/MLDC2025-12-10
06949517009028One +StepLDE2025-09-14
06949517008854One +StepLF-TL-28-I2025-06-27
06949517008861One +StepLF-TL-30-II2025-06-27
56949517070894One +StepLF-TL-23-I2025-06-27
56949517070900One +StepLF-TL-28-I2025-06-27
56949517070917One +StepLF-TL-30-II2025-06-27
06949517008878One +StepLDE2025-06-27
06949517002418Twist Lancet (30G)LF-TL-302019-04-30
06949517008021Twist Lancet(30G)LF-TL-302024-11-01
56949517070887Twist Lancet(30G)LF-TL-302024-11-01
06949517007024N/MLDF2024-05-28
06949517004313Twist Lancet(30G)LF-TL-302020-10-16
06949517004320Twist Lancet(30G)LF-TL-302020-10-16
06949517004337Twist LancetLF-TL-302020-10-16
06949517004344Twist Lancet(30G)LF-TL-302020-10-16
06949517004351Twist Lancet (30G)LF-TL-302021-06-08

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
06949517008854One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27