Rightest

GUDID 00883489001078

BIONIME CORPORATION

Home-use/point-of-care blood glucose monitoring system IVD
Primary Device ID00883489001078
NIH Device Record Key27689940-8558-4525-ae73-22d1a7f2845c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRightest
Version Model NumberGS100
Company DUNS658637244
Company NameBIONIME CORPORATION
Device Count25
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100883489001078 [Primary]
GS100883489001085 [Package]
Package: box [2 Units]
In Commercial Distribution
GS110883489001082 [Package]
Contains: 00883489001085
Package: case [20 Units]
In Commercial Distribution
GS120883489001089 [Package]
Contains: 10883489001082
Package: carton [12 Units]
In Commercial Distribution
GS180883489001074 [Unit of Use]

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-12-14

On-Brand Devices [Rightest]

00883489310293GM250
00883489001603GC300
00883489001498GS100
20883489001461GP200
20883489001423GS100
00883489001405GS300
20883489001164GS550
20883489001140GM550
00883489001078GS100
20883489001065GM100
00883489001047GC300
20883489001034GS300
00883489001009GM300
0088348900203725 pcs strips(80883489002033) per vial, 2 vials(00883489002037) per box
008834890019931 meter - 00883489001986 1 lancing device - 00883489002013 1 control solution -00883489002020
00883489001306single lancing device

Trademark Results [Rightest]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RIGHTEST
RIGHTEST
78326886 3077438 Live/Registered
Bionime Corporation
2003-11-12

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