Catalog Number

-

Brand Name

Assure® Platinum BLOOD GLUCOSE TEST STRIPS

Version/Model Number

500010

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092104,K092104,K092104

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

e1476817-ef7e-43af-892f-85d909f479a9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10015482500105

Quantity per Package

12

Contains DI Package

00015482500108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack