RIGHTEST GT333 Blood Glucose Monitoring System

GUDID 20883489001850

BIONIME CORPORATION

Glucose monitoring system IVD, home-use
Primary Device ID20883489001850
NIH Device Record Key0b4f421a-f4eb-49fc-9ecc-664317b1b2b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIGHTEST GT333 Blood Glucose Monitoring System
Version Model NumberMeter
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 Productfalse
Single Usefalse
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 909 781 6969
Emailinfo@bionimeusa.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100883489001849 [Primary]
GS100883489001856 [Package]
Contains: 00883489001849
Package: paper [1 Units]
In Commercial Distribution
GS120883489001850 [Package]
Contains: 00883489001856
Package: paper [50 Units]
In Commercial Distribution

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 Date2019-10-16
Device Publish Date2019-10-08

Devices Manufactured by BIONIME CORPORATION

00883489002563 - GE2024-10-29 Kitbox
00883489002525 - SMARTMETER2024-01-26 kit only has one meter
00883489002501 - SMARTMETER2023-12-25 Control Solution-Level 2
00883489001306 - RIGHTEST2023-07-11 single lancing device
00883489001320 - GE2023-07-11 GE Lancing device
20883489002383 - ODM2020-01-27 1 meter - 00883489002372
00883489002396 - ODM2020-01-27 1 meter - 00883489002396
20883489002420 - ODM2020-01-27 25 strips - 80883489002415

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