Catalog Number

-

Brand Name

Easy Trak II Blood Glucose Meter

Version/Model Number

1

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

K052208,K052208

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

b9546ec6-952e-4f51-92d3-395f2dc7e913

Public Version Date

January 20, 2020

Public Version Number

1

DI Record Publish Date

January 10, 2020

Package DI Number

10850632007369

Quantity per Package

80

Contains DI Package

00850632007362

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton