Catalog Number

-

Brand Name

FortisCare Blood Glucose Test Strip

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"

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

5e3b46a1-b78e-4d69-b3a3-d6476b319888

Public Version Date

February 07, 2020

Public Version Number

1

DI Record Publish Date

January 30, 2020

Package DI Number

10885017000314

Quantity per Package

150

Contains DI Package

00885017000317

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton