Catalog Number

53420

Brand Name

STAT PROFILE

Version/Model Number

PRIME CCS COMP

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

K141907,K141907

Product Code

CEM

Product Code Name

ELECTRODE, ION SPECIFIC, POTASSIUM

Public Device Record Key

2ead787f-c363-4b55-910c-26ea3af14706

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 06, 2017

Package DI Number

10385480534205

Quantity per Package

1

Contains DI Package

00385480534208

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box