Catalog Number

-

Brand Name

ReliOn® Confirm Pink Blood Glucose Monitoring System

Version/Model Number

712003

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

a174d6c7-cead-491f-b354-5f5b6c6c4e97

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2016

Package DI Number

10605388860153

Quantity per Package

4

Contains DI Package

00605388860156

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack