Catalog Number

-

Brand Name

On Call Vivid Glucose Control Solution Kit

Version/Model Number

G125-122

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

K112653,K112653,K112653

Product Code

JJX

Product Code Name

Single (specified) analyte controls (assayed and unassayed)

Public Device Record Key

2f90ded7-cca0-4e7f-b8f2-908f9c54489c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10682607556318

Quantity per Package

24

Contains DI Package

00682607556311

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case