Catalog Number

-

Brand Name

FortisCare Self-Monitoring Blood Glucose System

Version/Model Number

EasyMax T1 Pro

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

17de6210-fa08-475a-8794-560ab1d4e92b

Public Version Date

February 07, 2020

Public Version Number

1

DI Record Publish Date

January 30, 2020

Package DI Number

10885017000307

Quantity per Package

20

Contains DI Package

00885017000300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton