ODM 99GM291I01

GUDID 00883489001504

The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control solution(00883489001580),10 pcs/set of lancet(Sterile)(00883489001597) and 10 pcs/vial of strips_iGlucose Strip(00883489001573).

BIONIME CORPORATION

Glucose monitoring system IVD, home-use
Primary Device ID00883489001504
NIH Device Record Key24bd8864-462f-451d-80ea-dc478ffab99e
Commercial Distribution StatusIn Commercial Distribution
Brand NameODM
Version Model NumberiGlucose Blood Glucose Monitoring System
Catalog Number99GM291I01
Company DUNS658637244
Company NameBIONIME CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-844-445-8267
Emailsupport@iglucose.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100883489001504 [Primary]
GS100883489001511 [Package]
Package: box [1 Units]
In Commercial Distribution
GS100883489001566 [Package]
Package: combo [1 Units]
In Commercial Distribution
GS100883489001573 [Package]
Package: combo [10 Units]
In Commercial Distribution
GS100883489001580 [Package]
Package: combo [1 Units]
In Commercial Distribution
GS100883489001597 [Package]
Package: combo [10 Units]
In Commercial Distribution
GS110883489001518 [Package]
Contains: 00883489001511
Package: paper box [6 Units]
In Commercial Distribution
GS120883489001508 [Package]
Contains: 10883489001518
Package: paper carton [8 Units]
In Commercial Distribution
GS120883489001515 [Package]
Contains: 00883489001511
Package: carton [40 Units]
Discontinued: 2020-01-03
Not in Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-06
Device Publish Date2017-07-19

On-Brand Devices [ODM]

00883489001542iGlucose test strips
00883489001504The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control
2088348900242025 strips - 80883489002415
008834890023961 meter - 00883489002396
208834890023831 meter - 00883489002372

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