FDA.reportPublic FDA data

EasyTouch

Primary DI
MHC18260812
Brand
EasyTouch
Company
MHC MEDICAL PRODUCTS, LLC
Model
826081
Device description
EasyTouch 26G Pressure Activated Safety Lancet
Published
2025-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222376000Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)Shandong Lianfa Medical Plastic Products Co. , Ltd.2022-10-03FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
MHC18260812PrimaryHIBCC0
MHC18260810Unit of UseHIBCC0

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.

Regulatory Flags#

DUNS number
169895245
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
MHC18018252EasyTouch8018252026-03-17
MHC18018382EasyTouch8018382026-03-17
MHC18018250EasyTouch8018252026-03-17
MHC182032552EasyTouch82032552026-01-30
MHC182512552EasyTouch82512552026-01-30
MHC182532552EasyTouch82532552026-01-30
MHC182032550EasyTouch82032552026-01-30
MHC182512550EasyTouch82512552026-01-30
MHC1101665142EasyTouch101665142026-01-07
MHC14233252EasyTouch4233252026-01-07
MHC14251162EasyTouch4251162026-01-07
MHC14251252EasyTouch4251252026-01-07
MHC14301062EasyTouch4301062026-01-07
MHC14301082EasyTouch4301082026-01-07
MHC14305062EasyTouch4305062026-01-07
MHC14305082EasyTouch4305082026-01-07
MHC162715532EasyTouch62715532026-01-07
MHC162815532EasyTouch62815532026-01-07
MHC162915532EasyTouch62915532026-01-07
MHC163015532EasyTouch63015532026-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428359112CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFMK2026-06-04
00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010106SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010205SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010304SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
10840330705605ProCureTwin Med, LLCFMK2026-04-22
10840330705612ProCureTwin Med, LLCFMK2026-04-22
10840330705629ProCureTwin Med, LLCFMK2026-04-22
10840330705636ProCureTwin Med, LLCFMK2026-04-22
10840330705643ProCureTwin Med, LLCFMK2026-04-22
10840330705650ProCureTwin Med, LLCFMK2026-04-22
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393408Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393415Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393422Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393439Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393460Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393477Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393484Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
16931918130408Cardinal HealthGRI Medical & Electronic Technology Co., Ltd.FMK2025-06-20
16931918166803Cardinal HealthGRI Medical & Electronic Technology Co., Ltd.FMK2025-06-20
16945630132435STERiLANCE Elite Disposable Safety LancetSterilance Medical (Suzhou) Inc.FMK2024-10-23