Catalog Number

-

Brand Name

GoodSense

Version/Model Number

8000-10284

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

-

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

2303f69e-93b2-4dfb-9644-a61398be0b74

Public Version Date

December 03, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

00370030128396

Quantity per Package

1

Contains DI Package

30370030128397

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton