Catalog Number

-

Brand Name

SD GlucoNavii Blood Glucose Test Strip

Version/Model Number

01GS11

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

K100398,K100398,K100398

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

82157bac-cf92-4bc7-8915-29a36649918d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 23, 2017

Package DI Number

0887473000023

Quantity per Package

2

Contains DI Package

00887473000160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-