Catalog Number

-

Brand Name

EasyMax V Self-Monitoring Blood Glucose System

Version/Model Number

EMV

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

386fa816-ee81-4be7-b6d1-2b086c430327

Public Version Date

July 19, 2019

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

01885017000057

Quantity per Package

20

Contains DI Package

00885017000058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cartoon