FDA.reportPublic FDA data

TD-5052 AKTIVSAFE LANCET (Sterile) (21G) (100PCS/BOX)

Primary DI
04719893237139
Brand
TD-5052 AKTIVSAFE LANCET (Sterile) (21G) (100PCS/BOX)
Company
TAIDOC TECHNOLOGY CORPORATION
Model
TD-5052
Published
2025-11-25
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
K220370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220370000Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd.2022-05-19FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719893237139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719893237139047198932371394719893237139

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658530993
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719893233827XPER Technology Procheck Witty Procheck Smart Blood Glucose Test StripsTD-43352025-10-30
04719893237153TD-5052 AKTIVSAFE LANCET (Sterile) (26G) (100PCS/BOX)TD-50522025-11-25
04719893237177TD-5052 AKTIVSAFE LANCET (Sterile) (30G) (100PCS/BOX)TD-50522025-11-25
04710469874642Uright TD-1242 Forehead ThermometerTD-1242A2025-10-30
04710469879548XPER Technology Multi-Functional Monitoring System Procheck SmartTD-41402025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTD-41432025-10-30
04710636645921MbH (Mobile Health) TD-3140 Blood Pressure TD-31402025-10-30
04719893233834XPER Technology Procheck Witty Procheck Smart Total Cholesterol Test StripsTD-46422025-10-30
04719893233841XPER Technology Procheck Witty Procheck Smart B-Ketone Test StripsTD-46312025-10-30
04710469874635CLEVER TD-1242 Forehead ThermometerTD-1242B2025-10-29
04713106028187URIGHT Hemoglobin A1c AnalyzerTD-46112025-03-26
04710469873409Forehead Thermometer TD-1261TD-12612020-02-20
04710636640162TD-THIN Sterile Lancets (100pcs/box)TD-50842023-08-31
04717095034143MbH Fingertip Pulse OximeterTD-82552020-05-15
04710469873973CLEVER TD-1242 FOREHEAD THERMOMETERTD-12422021-10-28
04710469874581DIRECT SUPPLY Attendant ACTT-1 Tympanic ThermometerTD-11072020-06-01
04710469874598DIRECT SUPPLY Attendant Tympanic Thermometer Probe Cover (300pce/Box)TD-11072020-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16945630132442STERiLANCE Elite Disposable Safety LancetSterilance Medical (Suzhou) Inc.FMK2024-10-23