Catalog Number

-

Brand Name

On Call Pro Blood Glucose Test Strips

Version/Model Number

G135-10L

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161867,K161867,K161867,K161867

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

db39d04e-b74c-4de5-9444-c67eb1f2011d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10682607558213

Quantity per Package

12

Contains DI Package

00682607558216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case