FDA.reportPublic FDA data

N/M

Primary DI
06949517009462
Brand
N/M
Company
Shandong Lianfa Medical Plastic Products CO.,LTD
Model
LDC
Published
2025-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
QRLMultiple Use Blood Lancet For Single Patient Use Only

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2
QRLMultiple Use Blood Lancet For Single Patient Use OnlyGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06949517009462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06949517009462069495170094626949517009462

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
421330121
Device count
1
Premarket exempt
true
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
06949517009028One +StepLDE2025-09-14
06949517008847One +StepLF-TL-23-I2025-06-27
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
00860015786890True IntegralTRUE INTEGRAL INCQRK2026-05-28
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
00301936020217MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
00301936021214MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
16945630142007STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
16945630142014STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142021STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142038STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142045STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142069STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
00197344174433CARINGMEDLINE INDUSTRIES, INC.QRK2026-03-03
16945630141291STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141307SinocareSterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141284STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-12-31
MHC1808002EasyTouchMHC MEDICAL PRODUCTS, LLCQRL2025-11-10
MHC1826101EasyTouchMHC MEDICAL PRODUCTS, LLCQRK2025-11-10
20197344111838MEDLINEMEDLINE INDUSTRIES, INC.QRK2025-10-22
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
MHC1708001Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
MHC1730101Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
MHC1732101Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
16945630139311STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-09-10
16945630139328STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-09-10
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20