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

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
04719893239003XPER Technology Lactate Monitoring System L1L12026-08-03
04719893239010XPER Technology Lactate Test Strips L1 (25pcs/box)L12026-08-03
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
00840216123502ReadyLanceAsp Global, LLCFMK2026-11-02
00840216123526ReadyLanceAsp Global, LLCFMK2026-11-02
00840216123557ReadyLanceAsp Global, LLCFMK2026-11-02
00840216123571ReadyLanceAsp Global, LLCFMK2026-11-02
00840216123595ReadyLanceAsp Global, LLCFMK2026-11-02
00840216123861ReadyLanceAsp Global, LLCFMK2026-11-02
00840216123885ReadyLanceAsp Global, LLCFMK2026-11-02
00840216124042MediHeelAsp Global, LLCFMK2026-11-02
00840216124158MediHeelAsp Global, LLCFMK2026-11-02
00840216123694NovaPlusAsp Global, LLCFMK2026-10-30
00840216123908ReadyLanceAsp Global, LLCFMK2026-10-30
00840216123922ReadyLanceAsp Global, LLCFMK2026-10-30
16931918161877AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-10-28
16931918171425AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-10-28
10197344235391MEDLINEMEDLINE INDUSTRIES, INC.FMK2026-10-13
00732671009203PipAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMK2026-09-24
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