Catalog Number

03P78-25

Brand Name

i-STAT

Version/Model Number

03P78-25

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CHL

Product Code Name

ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Public Device Record Key

1106bd6b-5268-4873-a25e-2944edb0444f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Package DI Number

00054749000067

Quantity per Package

25

Contains DI Package

10054749000064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case