Catalog Number

-

Brand Name

ReliOn® Confirm/micro Blood Glucose Test Strips

Version/Model Number

710050 / 712100

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

Yes

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

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

e505bc5d-1d56-4781-86e8-160a189d2e2f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 17, 2017

Package DI Number

20605388564478

Quantity per Package

40

Contains DI Package

10605388564471

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Shipper