Catalog Number

-

Brand Name

ReliOn® Prime Blood Glucose Monitoring System

Version/Model Number

701103

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

K091102,K091102

Product Code

NBW

Product Code Name

SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Public Device Record Key

4b18dbcb-6abc-4c5d-aca6-7e9a6f38a9ca

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

10605388022933

Quantity per Package

4

Contains DI Package

00605388022936

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack