Catalog Number

-

Brand Name

ReliOn® Confirm Blue Blood Glucose Monitoring System

Version/Model Number

712002

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

8a2fa6aa-e723-4053-b83d-f499226760ad

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2016

Package DI Number

10605388860160

Quantity per Package

4

Contains DI Package

00605388860163

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack