FDA.reportPublic FDA data

LinkSun

Primary DI
00810011730762
Brand
LinkSun
Company
Tianjin Huahong Technology Co., Ltd.
Model
XXII, 30G
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810011730769PackageGS1100In Commercial Distribution
00810011730762PrimaryGS10
50810011730767Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081001173076910810011730769
00810011730762008100117307628100117307620810011730762
5081001173076750810011730767

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
421272490
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810011730748HuahongXXV, 26G2026-07-10
00810011730755leraiseIC, 30G2026-07-10
00810011730779VivaGuardIK, 30G2026-07-10
00810011730786VivaGuardHH-XIII-T2026-07-10
00810011730793HuahongIK, 28G2026-07-10
00810011730809huahongType VIA, 32G(0.23x4mm) ETW2026-07-10
00810011730816QikDiagOrdinary Type, 33G(0.20×4mm)2026-07-10
00810011730717HuahongXXII, 30G2026-05-21
00810011730724HuahongXXII, 30G2026-05-21
00810011730731HuahongXXV, 26G2026-05-21
00810011730632HuahongXXIII, 16G2025-07-23
00810011730700GoodLifeHH-XIII-T2026-05-11
00810011730694GoodLifeIK, 30G2026-05-09
00810011730687GoodLifeIK, 28G2026-05-06
00810011730670AuQtyOrdinary Type2026-03-27
00810011730649HuahongIK,30G2025-12-24
50810011730644HuahongIK,30G2025-12-24
00810011730656HuahongHH-XIII-T2025-12-24
00810011730663AllevyHH-X-T2025-12-24
10810011730639HuahongXXIII, 16G2025-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810011730748HuahongTianjin 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
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