Catalog Number

-

Brand Name

ReliOn® Prime Blood Glucose Test Strips

Version/Model Number

700050 / 700100

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

K091102,K091102,K091102,K091102,K091102

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

0e76da1c-5403-4e01-8200-f9c8d5036c20

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 17, 2017

Package DI Number

10605388022940

Quantity per Package

12

Contains DI Package

00605388022943

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack