FDA.reportPublic FDA data

VivaGuard Safety Lancets (26G)

Primary DI
00840423500455
Brand
VivaGuard Safety Lancets (26G)
Company
ABOUND Diagnostics, Inc.
Model
VGL02-2U2
Catalog number
VGL02-2U2
Device description
VivaGuard Safety Lancets (26G)
Published
2025-04-11
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

Contact Domains#

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
00840423500455PackageGS150In Commercial Distribution
00840423500172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840423500455008404235004558404235004550840423500455
00840423500172008404235001728404235001720840423500172

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancet, single-useA sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8889696928lmariano@abounddiagnostics.com

Regulatory Flags#

DUNS number
119217208
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00840423500028VivaGuard Ino Blood Glucose Test StripsVGS01-378VGS01-3782025-06-06
00840423500035VivaGuard Ino Control SolutionVGC01-373VGC01-3732025-06-06
00840423500059VivaGuard Ino Smart Blood Glucose MeterVGM04-665VGM04-6652025-06-06
00840423500684VivaGuard Ino Blood Glucose Test StripsVGS01-378VGS01-3782025-06-06
00840423500691VivaGuard Ino Control SolutionVGC01-373VGC01-3732025-06-06
00840423500707VivaGuard Ino Smart Blood Glucose MeterVGM04-665VGM04-6652025-06-06
00840423500004VivaGuard Ino Blood Glucose Meter VGM01-373VGM01-3732025-06-03
00840423500073VivaGuard Lancets (21G)VGL01-2U5VGL01-2U52025-04-11
00840423500080VivaGuard Lancets (23G)VGL01-2U4VGL01-2U42025-04-11
00840423500097VivaGuard Lancets (26G)VGL01-2U3VGL01-2U32025-04-11
00840423500134VivaGuard Lancing Device VGD01-381VGD01-3812025-04-11
00840423500141VivaGuard Safety Lancets (18G)VGL02-2U5VGL02-2U52025-04-11
00840423500165VivaGuard Safety Lancets (23G)VGL02-2U3VGL02-2U32025-04-11
00840423500172VivaGuard Safety Lancets (26G)VGL02-2U2VGL02-2U22025-04-11
00840423500189VivaGuard Safety Lancets (28G)VGL02-382VGL02-3822025-04-11
00840423500196VivaGuard Safety Lancets (30G)VGL02-2U1VGL02-2U12025-04-11
00840423500202CHOSEN Infrared Forehead ThermometerFTH800FTH8002025-04-11
00840423500363VivaGuard Lancets (33G)VGL01-2U1VGL01-2U12025-04-11
00840423500516VivaGuard Lancets (21G)VGL01-2U5VGL01-2U52025-04-11
00840423500509VivaGuard Lancets (23G)VGL01-2U4VGL01-2U42025-04-11

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