Catalog Number

-

Brand Name

EasyMax LTC Self-Monitoring Blood Glucose System

Version/Model Number

EMMU

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

-

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

914e93fc-f2d2-4864-84da-5fdd76174f34

Public Version Date

June 23, 2020

Public Version Number

2

DI Record Publish Date

May 16, 2018

Package DI Number

01885017000101

Quantity per Package

26

Contains DI Package

00885017000102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton