FDA.reportPublic FDA data

GOJJI LANCET 30G-GLUCOSE TEST STRIP

Primary DI
00850001462303
Brand
GOJJI LANCET 30G-GLUCOSE TEST STRIP
Company
GOJJI, INC.
Model
v1
Published
2020-04-08
Public version status
Update
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
FMKLancet, Blood
LFRGlucose Dehydrogenase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001462303PrimaryGS10
08500014623032Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001462303008500014623038500014623030850001462303
08500014623032085000146230328500014623032

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancing device tipA sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006572586
Device count
200
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001462327GOJJI BLOOD GLUCOSE TEST STRIPV12020-04-08
00850001462396GOJJI LANCET 30G-GLUCOSE TEST STRIPv12020-04-08
00850001462136GOJJI Plus TestNGo MULTIFUNCTION (GLUC-KETONE) METERV12026-02-01
00850001462112GOJJI MULTIFUNCTION (GLUC-KETONE) METERV12020-04-20
00850001462129GOJJI MULTIFUNCTION (GLUC-KETONE) METERV12020-04-20
00850001462419GOJJI KETONE CONTROL SOLUTION-L1v12020-04-20
00850001462006GOJJI MULTIFUNCTION (GLUC-KETONE) KTV12020-04-08
00850001462037GOJJI MULTIFUNCTION (GLUC-KETONE) KTV12020-04-08
00850001462334GOJJI BLOOD KETONE TEST STRIPv12020-04-08
00850001002011GOJJI BLOOD PRESSURE WELCOME KITV12020-12-23
00850001462402GOJJI GLUCOSE CONTROL SOLN-NORMALv12020-04-20
00850001462105GOJJI LANCING DEVICE WITH CLEAR CAPV12020-04-08
00850001462358GOJJI LANCETS 30Gv12020-04-08

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
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
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
10193489006476MedlineMEDLINE INDUSTRIES, INC.FMK2024-03-05