RIGHTEST GT333 Control Solution

GUDID 20883489001935

Glucose monitoring system IVD, home-use

Primary Device ID	20883489001935
NIH Device Record Key	aef117fd-0c22-446d-a06b-fbf4e36a309f
Commercial Distribution Status	In Commercial Distribution
Brand Name	RIGHTEST GT333 Control Solution
Version Model Number	Level 2
Company DUNS	658637244
Company Name	BIONIME CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Phone	1 909 781 6969
Email	info@bionimeusa.com

Handling Environment Temperature

Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	00883489001924 [Primary]
GS1	00883489001931 [Package] Contains: 00883489001924 Package: Paper [1 Units] In Commercial Distribution
GS1	10883489001938 [Package] Contains: 00883489001931 Package: paper [120 Units] In Commercial Distribution
GS1	20883489001935 [Package] Contains: 10883489001938 Package: paper [6 Units] In Commercial Distribution

JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

Steralize Prior To Use	false
Device Is Sterile	false