Catalog Number

-

Brand Name

FortisCare Blood Glucose Test Strip

Version/Model Number

EasyMax G1 FTS

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"

Yes

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

93eb5a64-9334-42d4-a518-011bb60d2d5e

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 16, 2021

Package DI Number

10885017000260

Quantity per Package

162

Contains DI Package

00885017000263

Package Discontinue Date

April 16, 2021

Package Status

Not in Commercial Distribution

Package Type

carton