RIGHTEST GT333 Blood Glucose Test Strip

GUDID 20883489001911

BIONIME CORPORATION

Glucose monitoring system IVD, home-use
Primary Device ID20883489001911
NIH Device Record Keye1bf6ef8-e77a-49a5-8140-ca2950221e74
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIGHTEST GT333 Blood Glucose Test Strip
Version Model Number100PCS
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-Countertrue

Customer Support Contacts

Phone1 909 781 6969
Emailinfo@bionimeusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100883489001900 [Primary]
GS100883489001917 [Package]
Contains: 00883489001900
Package: paper [4 Units]
In Commercial Distribution
GS110883489001914 [Package]
Contains: 00883489001917
Package: paper [12 Units]
In Commercial Distribution
GS120883489001911 [Package]
Contains: 10883489001914
Package: paper [12 Units]
In Commercial Distribution
GS180883489001906 [Unit of Use]

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

On-Brand Devices [RIGHTEST GT333 Blood Glucose Test Strip]

20883489001911100PCS
2088348900189850 PCS
2088348900187425pcs

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