VivaGuard Ino Smart VGM04-665

GUDID 00853483008236

VivaGuard Ino Smart Blood Glucose Meter Only Kit

Able Diagnostics Inc

Glucose IVD, kit, electrometry
Primary Device ID00853483008236
NIH Device Record Keyd7301c5e-3aa8-4f5a-9af5-d0fe5f281cef
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivaGuard Ino Smart
Version Model NumberVGM04
Catalog NumberVGM04-665
Company DUNS080952036
Company NameAble Diagnostics Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853483008236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-11
Device Publish Date2021-02-03

On-Brand Devices [VivaGuard Ino Smart]

00853483008243VivaGuard Ino Smart Blood Glucose Meter
00853483008236VivaGuard Ino Smart Blood Glucose Meter Only Kit

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