FDA.reportPublic FDA data

VivaGuard Ino Smart Blood Glucose Meter

Primary DI
00840423500707
Brand
VivaGuard Ino Smart Blood Glucose Meter
Company
ABOUND Diagnostics, Inc.
Model
VGM04-665
Catalog number
VGM04-665
Device description
VivaGuard Ino Smart Blood Glucose Meter
Published
2025-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840423500707PackageGS127In Commercial Distribution
00840423500059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840423500707008404235007078404235007070840423500707
00840423500059008404235000598404235000590840423500059

GMDN Terms#

Term, Definition table
TermDefinition
Glucose analyser IVD, home-useAn electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119217208
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
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
00840423500400VivaGuard Lancets (26G)VGL01-2U3VGL01-2U32025-04-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
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30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00010939958617TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2023-09-12
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10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
00011822002783TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2021-08-31
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250458MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19