Catalog Number

-

Brand Name

RIGHTEST

Version/Model Number

GS700

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K190564,K190564,K190564,K190564,K190564

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

737f6329-a09a-477c-a222-9ce2fe017160

Public Version Date

September 20, 2019

Public Version Number

1

DI Record Publish Date

September 12, 2019

Package DI Number

00883489002044

Quantity per Package

2

Contains DI Package

00883489002037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-