FDA.reportPublic FDA data

VivaGuard Ino

Primary DI
00853483008052
Brand
VivaGuard Ino
Company
Able Diagnostics Inc
Model
VGM01
Catalog number
VGM01-373
Device description
VivaGuard Ino Blood Glucose Meter Only Kit
Published
2021-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160179000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160179000VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc.2017-04-21NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853483008052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853483008052008534830080528534830080520853483008052

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080952036
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853483008076VivaGuard InoVGC01VGC01-3712021-02-03
00853483008175VivaGuard InoVGC01VGC01-3732021-02-03
00853483008182VivaGuard InoVGS01VGS01-3782021-02-03
00853483008199VivaGuard InoVGC01VGC01-3722021-02-03
00853483008236VivaGuard Ino SmartVGM04VGM04-6652021-02-03
00853483008243VivaGuard Ino SmartVGM042021-02-03
00853483008007VivaGuard InoVGM01VGM01-3712021-02-02
00853483008014VivaGuard InoVGS01VGS01-3712021-02-02
00853483008151VivaGuard Ino VGM012021-02-02
00853483008021VivaGuardVGL01VGL01-3822021-02-09
00853483008038VivaGuardVGD01VGD01-3812021-02-09
00853483008137VivaGuardVGL02VGL02-3822021-02-09
00853483008144VivaGuardVGL01VGL01-3832021-02-09
00853483008250VivaGuard® HA-650 Non-Contact Infrared Forehead ThermometerHA-650HA-6502020-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860015091635KetoBMKETOBM USA LLCNBW2026-07-14
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04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706973medisana BG 150 Blood Glucose Monitoring SystemTYSON BIORESEARCH INC.NBW2026-07-13
04719869706980medisana BG 150 Blood Glucose Test Strips (50Tx2)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706997medisana BG 150 Control Solution (Level 2)TYSON BIORESEARCH INC.NBW2026-07-13
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
06225000563827Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
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06223015680010Be SureEPS BIO TECHNOLOGY CORP.NBW2026-05-07
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30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
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30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
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10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28