Catalog Number

-

Brand Name

On Call Vivid Blood Glucose Test Strips

Version/Model Number

G135-102

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

K112653,K112653,K112653,K112653

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

37114c05-485a-4c9c-9830-844eaa9c4b85

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20682607556223

Quantity per Package

12

Contains DI Package

10682607556226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton