FDA.reportPublic FDA data

Prodigy Pressure Activated Safety Lancets

Primary DI
00384849903389
Brand
Prodigy Pressure Activated Safety Lancets
Company
Prodigy Diabetes Care, LLC
Model
990338
Catalog number
990338
Device description
Prodigy Pressure Activated Safety Lancets 28G (100 ct)
Published
2018-08-21
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

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
30384849903380PackageGS110In Commercial Distribution
00384849903389PrimaryGS10
90384849903382Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038484990338030384849903380
00384849903389003848499033893848499033890384849903389
9038484990338290384849903382

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
832875905
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384840104006Prodigy No Coding Blood Glucose Test Strips0104000104002024-07-10
00384840518902Prodigy AutoCode Blood Glucose Monitoring System0518900518902016-09-22
00384840519008Prodigy Voice Blood Glucose Monitoring System0519000519002016-09-22
00384840528253Prodigy No Coding Blood Glucose Test Strips0528250528252016-09-21
00384840719507Prodigy Voice Blood Glucose Monitoring System0719500719502016-09-22
00384840725003Prodigy No Coding Blood Glucose Test Strips0725000725002016-09-21
00384840732001Prodigy No Coding Blood Glucose Test Strips0732000732002016-09-21
00384840761506Prodigy iConnect Blood Glucose Monitoring System0761500761502016-09-23
00384840528000Prodigy No Coding Blood Glucose Test Strips0528000528002016-09-21
00384840528109Prodigy No Coding Blood Glucose Test Strips0528100528102016-09-21
00384840751002Prodigy Combo Pre-Pack0751000751002016-09-21
00384840751507Prodigy Value Pack0751500751502016-09-21
00384840753006Prodigy No Coding Blood Glucose Test Strips0753000753002016-09-21
00384840517004PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips0517000517002020-09-22
00384840105003Prodigy No Coding Blood Glucose Test Strips0105000105002024-07-11
00384843104003Prodigy No Coding Blood Glucose Test Strips0104000104002024-07-10
00384840750500Prodigy No Coding Blood Glucose Test Strips750500750502019-01-16
00384840518858Prodigy AutoCode Blood Glucose Monitoring System0518850518852016-09-21
00384840701205Prodigy AutoCode Blood Glucose Monitoring System0701200701202016-09-21
00384840708020Prodigy Pocket Blood Glucose Monitoring System0708020708022016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536930407BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
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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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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