Catalog Number

45335

Brand Name

StatSensor

Version/Model Number

1.0

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K070068,K070068

Product Code

CGL

Product Code Name

ELECTRODE, ION BASED, ENZYMATIC, CREATININE

Public Device Record Key

e479a414-ed36-475e-a91a-acd062f88a82

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10385480453353

Quantity per Package

1

Contains DI Package

00385480453356

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton