FDA.reportPublic FDA data

VacSure EZ Care Pressure Activate Safety Lancet

Primary DI
00850014448462
Brand
VacSure EZ Care Pressure Activate Safety Lancet
Company
LABOTEK GROUP CORP
Model
VEZC-2122
Published
2024-12-03
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
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
00850014448479PackageGS1100In Commercial Distribution
10850014448476PackageGS120In Commercial Distribution
00850014448462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014448479008500144484798500144484790850014448479
1085001444847610850014448476
00850014448462008500144484628500144484620850014448462

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117338398
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014448424VacSure EZ Care Pressure Activate Safety LancetVEZC-30152024-12-03
00850014448431VacSure EZ Care Pressure Activate Safety LancetVEZC-30152024-12-03
00850014448332VACSURE Disposable TourniquetsVS-DTD2024-03-18
00850014448134VACSURE Uni-BandRR-1512024-03-18
00850014448158Labotek Spot BandageRR-1502024-03-18
00850014448172TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-XS2024-03-18
00850014448196TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-S2024-03-18
00850014448219TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-M2024-03-18
00850014448233TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-L2024-03-18
00850014448257TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-XL2024-03-18
00850014448349VACSURE Sharp ContainerRRI-1QT2024-03-18
00850014448356VACSURE Sharp ContainerRRI-5QT2024-03-18
00850014448363VACSURE Sharp ContainerRRI-2GAL2024-03-18
00850014448370VACSURE Sharp ContainerRRI-3GAL-S2024-03-18
00850014448387VACSURE Sharp ContainerRRI-8GAL2024-03-18
00850014448141VACSURE Uni-BandRR-1512024-03-18
00850014448165Labotek Spot BandageRR-1502024-03-18
00850014448189TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-XS2024-03-18
00850014448202TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-S2024-03-18
00850014448226TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-M2024-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10840330705650ProCureTwin Med, LLCFMK2026-04-22
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
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08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
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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