Catalog Number

-

Brand Name

RIGHTEST GT333 Blood Glucose Monitoring System

Version/Model Number

Meter

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

0b4f421a-f4eb-49fc-9ecc-664317b1b2b5

Public Version Date

October 16, 2019

Public Version Number

1

DI Record Publish Date

October 08, 2019

Package DI Number

20883489001850

Quantity per Package

50

Contains DI Package

00883489001856

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

paper