Catalog Number

34717

Brand Name

STAT PROFILE

Version/Model Number

PHOX PLUS L

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

K012058,K012058

Product Code

CEM

Product Code Name

ELECTRODE, ION SPECIFIC, POTASSIUM

Public Device Record Key

c79bd02a-5424-4ce6-83e4-df4639c7270b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10385480347171

Quantity per Package

1

Contains DI Package

00385480347174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box