Catalog Number

-

Brand Name

On Call Express Blood Glucose Test Strips

Version/Model Number

G-135-10D

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

-

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

K132086,K132086,K132086,K132086

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

4e98178e-ac52-4082-a520-90b7856fd39d

Public Version Date

April 07, 2020

Public Version Number

1

DI Record Publish Date

March 30, 2020

Package DI Number

20024291121842

Quantity per Package

48

Contains DI Package

10024291121845

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE