Catalog Number

-

Brand Name

COOL

Version/Model Number

520050

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

K103396,K103396,K103396,K103396

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

1e5f0452-7bff-4871-a285-fd9bef9ce762

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20885325000768

Quantity per Package

45

Contains DI Package

10885325000761

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case Carton