FDA.reportPublic FDA data

EasyTouch

Primary DI
MHC18300612
Brand
EasyTouch
Company
MHC MEDICAL PRODUCTS, LLC
Model
830061
Device description
EasyTouch 30G 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
MHC18300612PrimaryHIBCC0
MHC18300610Unit 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
MHC18140012EasyTouch8140012026-09-22
MHC18140032EasyTouch8140032026-09-22
MHC18140052EasyTouch8140052026-09-22
MHC18140102EasyTouch8140102026-09-22
MHC18140202EasyTouch8140202026-09-22
MHC18140302EasyTouch8140302026-09-22
MHC18140602EasyTouch8140602026-09-22
MHC18290272EasyTouch8290272026-09-22
MHC18310472EasyTouch8310472026-09-22
MHC18313672EasyTouch8313672026-09-22
MHC18320872EasyTouch8320872026-09-22
MHC18323672EasyTouch8323672026-09-22
MHC18340012EasyTouch8340012026-09-22
MHC18340032EasyTouch8340032026-09-22
MHC18340052EasyTouch8340052026-09-22
MHC18340102EasyTouch8340102026-09-22
MHC18340202EasyTouch8340202026-09-22
MHC18340302EasyTouch8340302026-09-22
MHC18340602EasyTouch8340602026-09-22
MHC18290252EasyTouch8290252016-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00732671009203PipAMITY HOLDINGS, LLCFMK2026-09-24
00199536930438BluelineTransparent Supply Solutions Ltd.FMK2026-08-14
00199536930445BluelineTransparent Supply Solutions Ltd.FMK2026-08-14
00199536930452BluelineTransparent Supply Solutions Ltd.FMK2026-08-14
00199536930469BluelineTransparent Supply Solutions Ltd.FMK2026-08-14
00199536930476BluelineTransparent Supply Solutions Ltd.FMK2026-08-14
00199536930483BluelineTransparent Supply Solutions Ltd.FMK2026-08-14
M99260222818UPC3MedtLiteCarelife (usa) Inc.FMK2026-08-07
M99260223016UPC3MedtLiteCarelife (usa) Inc.FMK2026-08-07
00810011730748HuahongTianjin Huahong Technology Co., Ltd.FMK2026-07-10
00810011730762LinkSunTianjin Huahong Technology Co., Ltd.FMK2026-07-10
00810178887750Vive PrecisionVIVE HEALTH LLCFMK2026-06-26
00810178887767Vive PrecisionVIVE HEALTH LLCFMK2026-06-26
00816042013638FORAFORA CARE INC.FMK2026-06-23
00199536930407BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930414BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930421BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
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