Catalog Number

65651-220

Brand Name

GUARDIAN

Version/Model Number

65651-220

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

-

Product Code

CGX

Product Code Name

ALKALINE PICRATE, COLORIMETRY, CREATININE

Public Device Record Key

a98f9e46-4043-4d9e-b7ea-09d243d0a361

Public Version Date

January 08, 2021

Public Version Number

7

DI Record Publish Date

June 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-